MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for GPS3 SINGLE KIT W/BLOOD DRAW N/A 800-0675A manufactured by Zimmer Biomet, Inc..
[142752388]
(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).
Patient Sequence No: 1, Text Type: N, H10
[142752389]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01763 |
| MDR Report Key | 8535443 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-18 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2017-07-11 |
| Date Added to Maude | 2019-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GPS3 SINGLE KIT W/BLOOD DRAW |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-01-29 |
| Model Number | N/A |
| Catalog Number | 800-0675A |
| Lot Number | 701344 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-22 |