MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-31 for * 297294 manufactured by Becton Dickinson.
[17101410]
The trypticase soy broth (tsb) was used to plate a chest abscess swab specimen and to perform a gram stain. There was no growth of gram positive bacilli on the culture plate. The gram stained slide was pulled and reviewed. It was discovered after gram staining the tsb alone, that the source of the gram positive bacilli was the broth itself. The gram stain result was cancelled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2441080 |
| MDR Report Key | 2441080 |
| Date Received | 2012-01-31 |
| Date of Report | 2012-01-31 |
| Date of Event | 2012-01-20 |
| Report Date | 2012-01-31 |
| Date Reported to FDA | 2012-01-31 |
| Date Added to Maude | 2012-02-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | TRYPTICASE SOY BROTH |
| Product Code | JSD |
| Date Received | 2012-01-31 |
| Model Number | * |
| Catalog Number | 297294 |
| Lot Number | 1245773 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-31 |