MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for BD VACUTAINER? BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE 364955 manufactured by Becton, Dickinson & Co..
[132824525]
(b)(6). 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
[132824526]
It was reported that before use of the bd vacutainer? Boric acid sodium borate/formate c&s urine tubes 12 tubes were bowed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2018-04145 |
| MDR Report Key | 8237729 |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2018-01-11 |
| Date Added to Maude | 2019-01-10 |
| 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 | 8015652845 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| 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? BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE |
| Generic Name | TRANSPORT CULTURE MEDIUM |
| Product Code | JSL |
| Date Received | 2019-01-10 |
| Catalog Number | 364955 |
| Lot Number | 8011880 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-10 |