BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK
Report
- Report Number
- 1119779-2023-00033
- Event Type
- Malfunction
- Date Received
- January 18, 2023
- Date of Event
- January 11, 2023
- Report Date
- February 24, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6. INVESTIGATION SUMMARY: 252028 #2276065. WE COULD CONFIRM THIS ISSUE AS A REPORT FROM RETURNED SAMPLE. THE ISSUE WAS CONTAMINATION OF FUNGI. COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS LOT. AT THIS TIME. DHR DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE OBSERVED. IT INCLUDES BIOBURDEN TESTING. A VISUAL INSPECTION WAS PERFORMED ON 20 RETENTION SAMPLES OF THIS LOT. AS A RESULT, NO DEFECT WAS OBSERVED. NO TREND. THE ROOT CAUSE FOR THIS COULD NOT BE DETERMINED.
IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK MOLD WAS FOUND INS 3 UNOPENED SLEEVES. THE FOLLOWING INFORMATION THE CUSTOMER FOUND MOLD IN 3 UNOPENED SLEEVES.
IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK MOLD WAS FOUND INS 3 UNOPENED SLEEVES. THE FOLLOWING INFORMATION: THE CUSTOMER FOUND MOLD IN 3 UNOPENED SLEEVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369567 | BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 2276065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |