MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for BD VACUTAINER? EDTA 2K 367846 manufactured by Becton, Dickinson & Co..
[107511412]
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 for 115861 with the incident lot was not 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
[107511413]
It was reported that bd vacutainer? Edta 2k had issues with embedded foreign material in the tubes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2018-02617 |
| MDR Report Key | 7488465 |
| Date Received | 2018-05-04 |
| Date of Report | 2018-06-11 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2016-09-09 |
| Date Added to Maude | 2018-05-04 |
| 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? EDTA 2K |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | PJE |
| Date Received | 2018-05-04 |
| Catalog Number | 367846 |
| Lot Number | 6253692 |
| Device Expiration Date | 2017-12-31 |
| 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 | 2018-05-04 |