GPS MINI KIT W /ACD-A & BD -A/BLOOD D

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). REPORTED EVENT WAS CONFIRMED AS VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE FISTULA NEEDLE WAS BROKEN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE NEEDLE BROKEN IN THE PACKAGING IS ATTRIBUTED TO TRANSIT DAMAGE AS THE SUPPLIER NOTED NO NONCONFORMANCES DURING MANUFACTURING AND THE PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO BEING SHIPPED. ACCORDING TO THE CUSTOMER, A SMALLER GAUGE NEEDLE WAS USED TO COMPLETE THE BLOOD DRAW, RESULTING IN BLOOD COAGULATION IN THE TUBE. THE ROOT CAUSE OF THIS REPORTED ISSUE IS ATTRIBUTED TO USER ERROR, AS STATED IN THE IFU, AN 18-GAUGE APHERESIS NEEDLE MUST BE USED TO DRAW BLOOD. THE CUSTOMER NOTED THAT A SECOND KIT WAS OPENED TO RE-DRAW BLOOD, INDICATING THAT THEY HAD A USABLE 18-GAUGE NEEDLE AVAILABLE, BUT CHOSE TO USE A SMALLER NEEDLE WHICH RESULTED IN BLOOD COAGULATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

(B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE KIT WAS OPENED IT WAS FOUND THAT THE FISTULA NEEDLE WAS BROKEN INSIDE THE PACKAGING. THEY USED THEIR OWN FISTULA NEEDLE FROM THEIR CLINIC WHICH HAS A SMALLER GAUGE AND IT RESULTED IN BLOOD COAGULATING IN THE TUBE AFTER CENTRIFUGATION. ADDITIONAL BLOOD NEEDED TO BE DRAWN.