MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for BD VACUTAINER? K3E 7.2MG PLUS BLOOD COLLECTION TUBES 368860 manufactured by Becton, Dickinson And Company (bd).
[107503858]
Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. Bd had not received samples, but photos were provided by the customer facility for investigation. The photos were evaluated and the customer's indicated failure mode with the incident lot was observed. 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
[107503859]
It was reported that bd vacutainer? K3e 7. 2mg plus blood collection tubes had an abnormal additive that changed the color of the blood when collected. No serious injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-01250 |
| MDR Report Key | 7485119 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-05-03 |
| Date of Event | 2017-03-31 |
| Date Mfgr Received | 2017-03-31 |
| Device Manufacturer Date | 2016-07-15 |
| Date Added to Maude | 2018-05-03 |
| 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? K3E 7.2MG PLUS BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | PJE |
| Date Received | 2018-05-03 |
| Catalog Number | 368860 |
| Lot Number | 6197507 |
| Device Expiration Date | 2017-11-30 |
| 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 | 2018-05-03 |