MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-02 for VITEK CARD manufactured by Biomerieux.
[74407774]
(b)(6) discovered there was a packaging defect with vitek cards from biomerieux. Biomerieux changed their packaging had holes which appeared to be caused by the crimping of the packaging material at the mfr's factory. This defect was noticed after a few organisms were reported as highly resistent, but upon repeat testing requested by our infectious disease team, these organisms were shown to be very susceptible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069533 |
| MDR Report Key | 6541186 |
| Date Received | 2017-05-02 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-03 |
| Date Added to Maude | 2017-05-03 |
| 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 | VITEK CARD |
| Generic Name | VITEK CARD |
| Product Code | NGZ |
| Date Received | 2017-05-02 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-02 |