MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-18 for BD VACUTAINER? SST? II ADVANCE PLUS BLOOD COLLECTION TUBES 367957 manufactured by Becton, Dickinson And Company (bd).
[186302736]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Additional lot number: 9063874; additional expiration date: 2020-09-30. Additional device manufacture date: 2019-03-04.
Patient Sequence No: 1, Text Type: N, H10
[186302737]
It was reported that bd vacutainer? Sst? Ii advance plus blood collection tubes had air bubbles in the gel and reported erroneous results. The following information was provided by the initial reporter: "air-bubbles in gel, incorrect results outside the reference values. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2020-00262 |
| MDR Report Key | 9850058 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-03-04 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER? SST? II ADVANCE PLUS BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-18 |
| Model Number | 367957 |
| Catalog Number | 367957 |
| Lot Number | 9063876 |
| 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 UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |