MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for BD VACUTAINER? NO ADDITIVE (Z) TUBES 366703 manufactured by Becton, Dickinson & Co. (broken Bow).
[147344439]
Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[147344440]
Material no. 366703, batch no. 8303631. It was reported that after use of the bd vacutainer? No additive (z) tubes after plasma collection debris was presented in sample tube. There were four occurrences. The following information was provided by the initial reporter: it was reported after plasma collection debris was presented in sample tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-01229 |
| MDR Report Key | 8550413 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2018-10-30 |
| Date Added to Maude | 2019-04-25 |
| 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 | 0 |
| Brand Name | BD VACUTAINER? NO ADDITIVE (Z) TUBES |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | FMH |
| Date Received | 2019-04-25 |
| Catalog Number | 366703 |
| Lot Number | 8303631 |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-04-25 |