MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-11 for MARROWSTIM PAD KIT W/6 TUBES N/A 800-0611 manufactured by Zimmer Biomet, Inc..
[90306612]
Product has been received by zimmer biomet. "based on associated device history records, the product was made to print and correct materials. Product left conforming to print as there was no evidence that states otherwise. It is impossible to tell when/where the puncture in the sterile packaging most likely occurred. The supplier states there are multiple processes that would catch this failure and zimmer biomet does not alter the packaging once received from the supplier. " review of complaint history found no additional related issues for this item. Review of device history records found these units were released to distribution with no deviations or anomalies. 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. This report is being submitted late as it has been identified in remediation.
Patient Sequence No: 1, Text Type: N, H10
[90306613]
T was reported that during a bone marrow aspiration/autologous cell therapy procedure on (b)(6) 2016, when the nurse opened up the marrowstim pad kit, one of the 60 ml separators was found to have a hole in the sterile packaging. Another separator from another kit was used to complete the procedure. No further information has been provided. This device was not used on the patient. The compromised separator, along with the packaging, will be returned at the sponsor? S request.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-08496 |
| MDR Report Key | 6941430 |
| Date Received | 2017-10-11 |
| Date of Report | 2017-10-11 |
| Date of Event | 2016-01-07 |
| Date Mfgr Received | 2016-01-07 |
| Device Manufacturer Date | 2013-09-03 |
| Date Added to Maude | 2017-10-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MARROWSTIM PAD KIT W/6 TUBES |
| Generic Name | BIOLOGICS |
| Product Code | KNW |
| Date Received | 2017-10-11 |
| Returned To Mfg | 2016-01-14 |
| Model Number | N/A |
| Catalog Number | 800-0611 |
| Lot Number | 302168 |
| ID Number | N/A |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Brand Name | MARROWSTIM PAD KIT W/6 TUBES |
| Generic Name | BIOLOGICS |
| Product Code | JQC |
| Date Received | 2017-10-11 |
| Returned To Mfg | 2016-01-14 |
| Model Number | N/A |
| Catalog Number | 800-0611 |
| Lot Number | 302168 |
| ID Number | N/A |
| Device Expiration Date | 2018-05-31 |
| 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 | 2017-10-11 |