MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-08 for BD VACUTAINER? EDTA TUBES UNKNOWN manufactured by Becton Dickinson.
[107718867]
Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. Results: it is unknown if a sample will be returned for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. Conclusion: without a sample, an absolute root cause for this incident cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[107718868]
It was reported the bd vacutainer? Edta tubes were clotting , no report of medical interventions or serious injury
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00587 |
| MDR Report Key | 7496047 |
| Date Received | 2018-05-08 |
| Date of Report | 2018-04-27 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2014-03-26 |
| Date Added to Maude | 2018-05-08 |
| 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 |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? EDTA TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | PJE |
| Date Received | 2018-05-08 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-08 |