FDA Adverse Event
Malfunction
Summary report: N
BD BBL¿ SALMONELLA SHIGELLA AGAR
MDR report key: 16191101
·
Received January 17, 2023
Report
- Report Number
- 1119779-2023-00031
- Event Type
- Malfunction
- Date Received
- January 17, 2023
- Date of Event
- January 5, 2023
- Report Date
- January 12, 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
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INITIAL REPORTER FACILITY NAME: INVESTIGATION SUMMARY: 251181 #2277339. WE COULDN'T CONFIRM THIS ISSUE AS A REPORT BECAUSE NO PHOTO AND RETURNED SAMPLE. NO ISSUE IN RETENTION AND DHR. NO TREND. WE WILL CONTINUE TO MONITOR THIS LOT.
Description of Event or Problem · 0
IT WAS REPORTED THAT BD BBL¿ SALMONELLA SHIGELLA AGAR BACTERIA WAS FOUND IN THE MEDIA BEFORE USAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; BACTERIAL GROWTH WAS FOUND IN THE MEDIA BEFORE USAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 925431 | BD BBL¿ SALMONELLA SHIGELLA AGAR | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON, DICKINSON & CO. (SPARKS) | 2277339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |