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Medical Material Quality Control Message

MMQC-19-2180


Message Number: MMQC-19-2180
Released On: 17-Jul-19
Message Class: Informational
Material Type: MedSurg
MMQC\MMI Reference:
FDA Recall Reference:
ECRI Reference:
DLA Reference:
MFG Release Date:

Subject:

CAT GEN 7 Tourniquets Vacuum Sealed


Reason / Information:

Informational / MEDSURG / HIGH The Defense Health Agency Medical Logistics (DHA MEDLOG) has received a Product Quality Deficiency Report (PQDR), which is being adjudicated, from the operational field and has issued an Informational SAFETY ALERT on the Individual First Aid Kits (IFAKS) that contains ???Vacuum Sealed??? CAT GEN 7 Tourniquets.

Reason: The vacuum seal of the tourniquets causes a deformity of the tourniquet clips which causes a malfunction to occur. The sealing of the tourniquet inhibits the optimization and efficiency by creating a barrier in life threatening situations as evident by creating extra time to remove the tourniquet promptly. Additionally, due to the durability of the seal, breaking the seal with sharp objects (i.e.: knife and/or shears) increases the risk of damaging the tourniquet and self.

NOTE: This message is to alert the enterprise of the potential safety risk that may involve vacuum sealing tourniquets in IFAKS.


Disposition / Instructions:

DHA MEDLOG Recommendations:

1) Stop and/or pause vacuum sealing IFAKS pending manufacturer recommendation or guidance.

2) If vacuum sealing is necessary for kitting, please ensure the kitting company follows the manufacturer???s recommendations for components contained in IFAKS, to include tourniquets, to ensure best practices are correctly identified.

3) Customers are advised to conduct the following:

---Defective items that are identified need to be removed from first aid kit and replaced with non-vacuum sealed tourniquets as soon as possible.

---Please ensure a Standard Form 368, Product Quality Deficiency Report, is completed if defective tourniquets are suspected.

---Please ensure widest dissemination of information to all interested entities.

4) If customer(s) have any questions or concerns with regard to this notification, please contact the Chief of Quality and Optimization Branch at 301-619-9851.

NOTE: DHA Hazard, Alerts, and Recalls (HAR) program has not received a Manufacturer/Distributor notification of a product recall.


Service/Additional Instructions:



POC Contact Information:

US AIR FORCE
Email: usaf.detrick.afmoa.mbx.sgmp-scs-alerts@mail.mil
Phone (COMM): 301-619-4183
Phone (DSN): 343-4183
Fax: 301-619-2557

US ARMY
Email: usarmy.detrick.medcom-usamma.mbx.doc@mail.mil
Phone (COMM): 301-619-4198
Phone (DSN): 343-4198
Fax: 301-619-4468

US NAVY
Email: usn.detrick.navmedlogcomftdmd.list.mmqc@mail.mil
Phone (COMM): 301-619-3085
Phone (DSN): 343-3085
Fax: 301-619-2473

USAMMC-E
Email: usarmy.rheinland-pfalz.medcom-usammce.list.dtd-quality-assurance@mail.mil
Phone (COMM): 011-49-6331-86-7118/7181
Phone (DSN): 495-7118
Fax: 6218

Additional Message Recipients:

Please ensure dissemination of this information to the following:

Command Channels
Lab Staff
Medical Log Officers
Medical Staff
Supply Officers
Supported Activities/Centers

Message Dissemination Authorization

AF Activities will take action as prescribed in AFMAN41-209, Medical Logistics Support, Chapter 7. For MAJCOMS & NGB ??? This Msg has been transmitted to all designated subordinate medical activities

See Army Regulation (AR) 40-61, 28 January 2005, Chapter 4, and The Department Of The Army Supply Bulletin (SB 8-75-11) For Applicable Policies and Procedures.

DODD 5105.22 and DODD 6025.13


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