MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-12-18 for BBL MYCOBACTERIA GROWTH INDICATOR 7ML TUBE 245122 manufactured by Becton Dickinson.
[285641]
A tube innoculated with m. Tb atcc 27294, qc organism appeared to have evaporated. Crack parallel to seam of tube seen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2002-00007 |
| MDR Report Key | 434277 |
| Report Source | 05,06 |
| Date Received | 2002-12-18 |
| Date of Report | 2002-12-18 |
| Date of Event | 2002-11-21 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2002-12-27 |
| 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 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL MYCOBACTERIA GROWTH INDICATOR 7ML TUBE |
| Generic Name | CULTURE MEDIA |
| Product Code | JSD |
| Date Received | 2002-12-18 |
| Model Number | NA |
| Catalog Number | 245122 |
| Lot Number | 2203228 |
| ID Number | * |
| Device Expiration Date | 2003-07-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 423236 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Baseline Brand Name | BBL MYCOBACTERIA GROWTH INDICATOR 7ML TUBE |
| Baseline Generic Name | CULTURE MEDIA |
| Baseline Model No | NA |
| Baseline Catalog No | 245122 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-12-18 |