MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-06-04 for BACTEC MYCO/F-SPUTA CULTURE VIAL 4402187 manufactured by Becton Dickinson Microbiology Systems.
[64756]
Customer reported leaking around crimping of 6 vials after inoculation of specimen. Customer reported seal appeared loose and not tightly sealed. No death or serious injury has occurred as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1997-00008 |
| MDR Report Key | 96393 |
| Report Source | 05,06 |
| Date Received | 1997-06-04 |
| Date of Report | 1997-05-30 |
| Date of Event | 1997-05-28 |
| Date Facility Aware | 1997-05-28 |
| Report Date | 1997-05-30 |
| Date Mfgr Received | 1997-05-29 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 1997-06-09 |
| 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 | 1997-06-04 |
| 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 | 4 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 95166 |
| 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 | 1997-06-04 |