MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-08 for 221199 manufactured by Becton-dickinson.
[3638916]
One tube of thioglycollate medium without indicator was moldy upon receipt, despite the fact that the cap was secure and the tube showed no signs of damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031383 |
| MDR Report Key | 3283758 |
| Date Received | 2013-08-08 |
| Date of Report | 2013-08-07 |
| Date of Event | 2013-08-02 |
| Date Added to Maude | 2013-08-15 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR |
| Product Code | JSG |
| Date Received | 2013-08-08 |
| Catalog Number | 221199 |
| Lot Number | 309-2459 |
| Device Expiration Date | 2014-04-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON-DICKINSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-08 |