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? ECLIPSE? SIGNAL? BLOOD COLLECTION NEEDLE INTEGRATED HOLDER 368836 manufactured by Becton, Dickinson And Company (bd).
[107499975]
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[107499976]
It was reported that the bd vacutainer? Eclipse? Signal? Blood collection needle integrated holder is having issues with this product where the blood will pool in the chamber where the porous plug is located. After the chamber is filled with blood, all the other tubes are very slow to fill or not filling at all. Found during use. No reports of serious injury or medical intervention noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-00105 |
| MDR Report Key | 7485038 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2018-04-05 |
| Device Manufacturer Date | 2017-10-25 |
| 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? ECLIPSE? SIGNAL? BLOOD COLLECTION NEEDLE INTEGRATED HOLDER |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | PJE |
| Date Received | 2018-05-03 |
| Catalog Number | 368836 |
| Lot Number | 7298618 |
| Device Availability | * |
| Device Age | DA |
| 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 |