MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-26 for BECTON-DICKINSON 9724 manufactured by Becton Dickinson Microbiology Systems.
[60664]
Unable to obtain valid qc result for campylobacter cva agar. When challenged with e. Coli qc organism the isolate grows well on this selective media (inhibition, effect of agar not working. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011564 |
| MDR Report Key | 101013 |
| Date Received | 1997-06-26 |
| Date of Report | 1997-06-23 |
| Date of Event | 1997-05-22 |
| Date Added to Maude | 1997-06-30 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECTON-DICKINSON |
| Generic Name | CAMPY CVA AGAR |
| Product Code | LQP |
| Date Received | 1997-06-26 |
| Returned To Mfg | 1997-05-28 |
| Model Number | NA |
| Catalog Number | 9724 |
| Lot Number | FINWLF & E4NVSJ |
| ID Number | * |
| Device Expiration Date | 1997-07-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 99516 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | P.O. BOX 243 COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-26 |