MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-27 for BIOCUE STD KIT ACD-A W/BD 800-0613A manufactured by Zimmer Biomet, Inc..
[155642857]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[155642858]
It was reported that during the procedure, the incorrect size of separator was used and the blood was unable to be separated. The patient will undergo an additional surgery to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-03792 |
| MDR Report Key | 8934722 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-27 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-11-25 |
| Date Added to Maude | 2019-08-27 |
| 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 | 3 |
| Brand Name | BIOCUE STD KIT ACD-A W/BD |
| Generic Name | BIOLOGICS, INSTRUMENT |
| Product Code | JQC |
| Date Received | 2019-08-27 |
| Catalog Number | 800-0613A |
| Lot Number | 702282 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2019-08-27 |