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? NAF 3.0MG N2E 6.0MG PLUS BLOOD COLLECTION TUBES 367933 manufactured by Becton, Dickinson & Co..
[107964753]
Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. Result: 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 for (b)(6) with the incident lot was observed.
Patient Sequence No: 1, Text Type: N, H10
[107964754]
It was reported the bd vacutainer? Naf 3. 0mg n2e 6. 0mg plus blood collection tubes were having lip out of tube, no report of medical interventions or serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00554 |
| MDR Report Key | 7484543 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-04-25 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-20 |
| 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 & CO. |
| Manufacturer Street | 150 SOUTH 1ST AVENUE |
| Manufacturer City | BROKEN BOW NE 68822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68822 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? NAF 3.0MG N2E 6.0MG PLUS BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | PJE |
| Date Received | 2018-05-03 |
| Catalog Number | 367933 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-03 |