MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-02 for BD VACUTAINER? 9NC 0.129M PLUS BLOOD COLLECTION TUBES 363079 manufactured by Becton, Dickinson And Company (bd).
[107569419]
(b)(6). Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. Retention samples were selected from bd inventory for evaluation, and the customer's indicated failure mode for 94091 was not observed as all samples met specifications. A review of the manufacturing records was completed for the incident lot and no issues were identified.
Patient Sequence No: 1, Text Type: N, H10
[107569420]
It was reported that bd vacutainer? 9nc 0. 129m plus blood collection tubes "citrate-363079-underfill"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-00830 |
| MDR Report Key | 7481547 |
| Date Received | 2018-05-02 |
| Date of Report | 2018-04-25 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2017-05-29 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2018-05-02 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? 9NC 0.129M PLUS BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | PJE |
| Date Received | 2018-05-02 |
| Catalog Number | 363079 |
| Lot Number | 6243597 |
| Device Expiration Date | 2017-05-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-02 |