MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-02-18 for TB PHOSPHATE BUFFER * 669-500 manufactured by Scientific Device Laboratory.
[155391]
Laboratory had received false positive results from afb (acid fast bacilli) tests run on seven patients. The positive cultures revealed mycobacterium mucogenicum. Upon further laboratory research it was found out that the tb buffer was contaminated. On 12/30/98 laboratory received a call from scientific devices laboratory recalling tb buffer lot number 50418. Facility did not have this lot number. Facilities contaminated lot number is 32518. Calls to the manufacturer revealed buffer problems elsewhere and a comment about a laboratory grade water problem. No product was returned to the manufacturer. No serious illness has been noted as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 210673 |
| MDR Report Key | 210673 |
| Date Received | 1999-02-18 |
| Date of Report | 1999-02-17 |
| Date of Event | 1999-01-05 |
| Date Facility Aware | 1999-01-05 |
| Report Date | 1999-02-17 |
| Date Added to Maude | 1999-02-23 |
| 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 | TB PHOSPHATE BUFFER |
| Generic Name | MICROBIOLOGY BUFFER |
| Product Code | MWA |
| Date Received | 1999-02-18 |
| Model Number | * |
| Catalog Number | 669-500 |
| Lot Number | 50418 |
| ID Number | * |
| Device Expiration Date | 1999-06-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 204432 |
| Manufacturer | SCIENTIFIC DEVICE LABORATORY |
| Manufacturer Address | 411 EAST JARVIS DES PLAINES IL 60018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-02-18 |