MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for BBL TSA W/5% SHEEP BLOOD AGAR PLATES manufactured by Becton Dickinson And Company.
[122309842]
Bd bbl tsa w/ 5% sheep blood agar plates were found in lab testing to be inhibiting growth of gram negative pathogenic bacterial in culture. Therapy start date: (b)(6) 2018; therapy end date: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080196 |
| MDR Report Key | 7918939 |
| Date Received | 2018-09-27 |
| Date of Event | 2018-09-16 |
| Date Added to Maude | 2018-09-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BBL TSA W/5% SHEEP BLOOD AGAR PLATES |
| Generic Name | CULTURE MEDIA SELECTIVE AND NONDIFFERENTIAL |
| Product Code | JSJ |
| Date Received | 2018-09-27 |
| Returned To Mfg | 2018-09-26 |
| Lot Number | 8221508 |
| Device Expiration Date | 2018-11-30 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-27 |