GPS3 SINGLE KIT W/BLOOD DRAW
Received Apr 22, 2019 · Event occurred Oct 22, 2018
Report 0001825034-2019-01763 · MDR key 8535443
Device
Generic name
Supplies, Blood-bank
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
800-0675A
Lot number
701344
Product problems
- Device Damaged Prior to Receipt by User
- Device Damaged Prior to Receipt by User
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED A WHITE, FLAKY MATERIAL, WHICH WAS FROM THE TYVEK LID. THERE WAS EVIDENCE BY THE SEAL MARKS ON THE CAVITY THAT THE PRODUCT HAD BEEN SEALED AT ONE POINT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT IS DUE TO DEVICE MOVEMENT WITHIN THE CAVITY AND CAN BE ATTRIBUTED TO TRANSIT DAMAGE. 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. REPORT SOURCE: (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT WHEN THE PRODUCT WAS OPENED, IT APPEARED THAT THE INSIDE PACKAGING HAD BEEN DAMAGED, AND THERE WERE WHITE FLAKES OVER THE TUBE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN REPORTED.