MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-15 for BACTEC MYCO/F-SPUTA CULTURE VIAL 4402187 manufactured by Becton Dickinson Microbiology Systems.
[20889036]
Four vials from this lot have leaked after entry into the instrument. They appear to be leaking from the cap end of the vial. No death or serious injury has occurred as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1997-00006 |
| MDR Report Key | 91416 |
| Report Source | 05,06 |
| Date Received | 1997-05-15 |
| Date of Report | 1997-05-14 |
| Date of Event | 1997-04-29 |
| Date Facility Aware | 1997-04-29 |
| Report Date | 1997-05-14 |
| Date Mfgr Received | 1997-05-02 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 1997-05-20 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC MYCO/F-SPUTA CULTURE VIAL |
| Generic Name | CULTURE MEDIA |
| Product Code | JSC |
| Date Received | 1997-05-15 |
| Model Number | NA |
| Catalog Number | 4402187 |
| Lot Number | 0157A |
| ID Number | NA |
| Device Expiration Date | 1998-02-01 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 90307 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 211520999 US |
| Baseline Brand Name | BACTEC MYCO/F-SPUTA CULTURE VIAL |
| Baseline Generic Name | CULTURE MEDIA |
| Baseline Model No | NA |
| Baseline Catalog No | 4402187 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-15 |