MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-19 for BD VACUTAINER? PST? GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES 367960 manufactured by Becton, Dickinson & Co. (broken Bow).
[186299404]
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
[186299405]
It was reported that foreign matter occurred before use with a bd vacutainer? Pst? Gel and lithium heparin (lh) blood collection tubes. The following information was provided by the initial reporter, "have you had any customers reporting what appears to be imperfections in the tube? There are black particles that appear to be imbedded in the plastic? We are seeing these in the pst and sst tubes. Pst lot #9220492. The? Scratches? Around the black dot is where we tried to scrape it out with a needle, so the black is impeded in the plastic. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2020-00297 |
| MDR Report Key | 9855650 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-08-08 |
| Date Added to Maude | 2020-03-19 |
| 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 & CO. (BROKEN BOW) |
| 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 | 3 |
| Brand Name | BD VACUTAINER? PST? GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES |
| Generic Name | BLOOD COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-19 |
| Model Number | 367960 |
| Catalog Number | 367960 |
| Lot Number | 9220492 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. (BROKEN BOW) |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |