MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-01-19 for BBL MYCOBACTERIA GROWTH INDICATOR 7 ML TUBE 4345122 manufactured by Becton Dickinson Microbiology Systems.
[164334]
Customer reported one broken tube and two leaking tubes in instrument after inoculation of specimen. No exposure was indicated. No death or serious injury has occurred as a result of this event. Specimen was negative for the presence of acid fast bacilli.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1998-00007 |
| MDR Report Key | 206923 |
| Report Source | 05 |
| Date Received | 1999-01-19 |
| Date of Report | 1998-12-21 |
| Date of Event | 1998-12-18 |
| Date Mfgr Received | 1998-12-21 |
| Date Added to Maude | 1999-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL MYCOBACTERIA GROWTH INDICATOR 7 ML TUBE |
| Generic Name | CULTURE MEDIA |
| Product Code | JSC |
| Date Received | 1999-01-19 |
| Model Number | NA |
| Catalog Number | 4345122 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 200850 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-01-19 |