MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-08 for BACTEC 12 B MEDIUM 02004 manufactured by Diagnostic Instrument Div. Becton Dickinson Corp..
[17362]
Rptr has noticed a 4-fold increase in carbon 14 backgrounds over the last 4-6 months. User is concerned due to overall trend, even though levels are within mfr's specs. User has ruled out analyzer as source of problem and is concerned that tests indicate substrate breaking down. No direct infection control issue at this time. User is concerned over mfr's apparent lack of concern over trend.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007891 |
| MDR Report Key | 28597 |
| Date Received | 1995-12-08 |
| Date of Report | 1995-12-07 |
| Date of Event | 1995-07-01 |
| Date Added to Maude | 1995-12-12 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC 12 B MEDIUM |
| Generic Name | TB MYOBACTERIUM BROTH MEDIUM |
| Product Code | JSD |
| Date Received | 1995-12-08 |
| Catalog Number | 02004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29552 |
| Manufacturer | DIAGNOSTIC INSTRUMENT DIV. BECTON DICKINSON CORP. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-08 |