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.