BD BBL¿ SALMONELLA SHIGELLA AGAR
Report
- Report Number
- 1119779-2023-00177
- Event Type
- Malfunction
- Date Received
- February 24, 2023
- Date of Event
- February 7, 2023
- Report Date
- March 2, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY: 251181 #2298425. WE COULDN'T CONFIRM THIS ISSUE AS A REPORT FROM ATTACHED PHOTO. THE ISSUE WAS PRECIPITATION. THIS PRODUCT WAS ALREADY EXPIRED WHEN WE RECEIVED THIS REPORT. NO ISSUE WAS IN DHR, RETENTION SAMPLE. NO TREND. WE WILL CONTINUE TO MONITOR THIS LOT.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD BBL¿ SALMONELLA SHIGELLA AGAR BACTERIA WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDE BY THE INITIAL REPROTED: BEFORE USAGE, THE CUSTOMER FOUND THAT THE MEDIA WAS CONTAMINATED WITH BACTERIA RESEMBLING MOLD. THE MOLD-LIKE MATTER WAS FOUND ON THE SURFACE AND IN THE MEDIA.
IT WAS REPORTED THAT BD BBL¿ SALMONELLA SHIGELLA AGAR BACTERIA WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDE BY THE INITIAL REPORTED: BEFORE USAGE, THE CUSTOMER FOUND THAT THE MEDIA WAS CONTAMINATED WITH BACTERIA RESEMBLING MOLD. THE MOLD-LIKE MATTER WAS FOUND ON THE SURFACE AND IN THE MEDIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2058340 | BD BBL¿ SALMONELLA SHIGELLA AGAR | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON, DICKINSON & CO. (SPARKS) | 2298425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |