BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
Report
- Report Number
- 9680577-2021-00083
- Event Type
- Malfunction
- Date Received
- November 19, 2021
- Date of Event
- October 22, 2021
- Report Date
- January 5, 2022
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSG
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT 3841229 AGAINST TRYPTICASE¿ SOY AGAR II WITH 5% SHEEP BLOOD, CATALOG NUMBER 254053, LOT NUMBER 1216483. EVENT DESCRIPTION: IT WAS REPORTED THAT FIVE PLATES WERE FOUND TO BE CONTAMINATED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY OF THE AFFECTED BATCH AND CATALOG NUMBER WAS REVIEWED FOR THE PAST 12 MONTHS. THERE WERE NO SIMILAR COMPLAINTS REGISTERED. THEREFORE, A TREND COULD NOT BE IDENTIFIED. DHR REVIEW: THE BHR WAS REVIEWED. NO DEVIATIONS FROM VALIDATED PROCESSES WERE REGISTERED. FURTHERMORE THE AFFECTED BATCH MET ALL REQUIRED RELEASE SPECIFICATIONS AND NO DEVIATION WAS REGISTERED DURING QC RELEASE TESTING. SAMPLE ANALYSIS: PICTURE SAMPLE WAS PROVIDED SHOWING CONTAMINATION IN THE PLATE. RETAIN SAMPLES WERE ANALYZED. NO CONTAMINATION WAS DETECTED. INVESTIGATION CONCLUSION: ASEPTIC MANUFACTURING PROCESSES ARE UNABLE TO GUARANTEE STERILITY OF THE GIVEN PRODUCT. SINCE A 100 % INSPECTION IS NOT POSSIBLE FOR ASEPTIC PRODUCTS, STERILITY TESTING CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. THEREFORE, OCCASIONAL CONTAMINATION CANNOT BE PREVENTED. NEVERTHELESS, TO IMPROVE CUSTOMER EXPERIENCE, AN INTERDISCIPLINARY TEAM WAS FOUNDED TO FURTHER REDUCE THE OCCURRENCE OF THESE SUBLIMINAL CONTAMINATIONS. EFFECTIVENESS CHECKS INDICATE A SIGNIFICANT IMPROVEMENT TO THE SITUATION CAUSED BY THE TRIGGERED ACTIONS. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. EVALUATION RESULTS: BASED ON THE INTERNAL INVESTIGATION AND THE PROVIDED PICTURES, THE COMPLAINT WAS CONFIRMED. WE WOULD SUGGEST TO SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE AND PERFORMANCE SPECIFICATION AS IT IS DESCRIBED ON THE BD CERTIFICATE OF ANALYSIS. THIS IS CONSISTENT WITH INDUSTRY RECOMMENDATIONS FOR INSPECTION OF CULTURE MEDIA PRIOR TO USE (E.G. ¿GOOD PRACTICES FOR PHARMACEUTICAL MICROBIOLOGY LABORATORIES¿, WHO TECHNICAL REPORT SERIES, NO. 961, 2011, ANNEX 2; CHAPTER <1117> ¿MICROBIOLOGY BEST LABORATORY PRACTICES¿ THE UNITED STATES PHARMACOPEIA; AND THE DIFCO & BBL MANUAL). H3 OTHER TEXT : SEE H.10.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL CATALOG NUMBER 221239 WITH 510K NUMBER PREAMENDMENT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL CATALOG NUMBER 221239 WITH 510K NUMBER PREAMENDMENT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT 5 PLATES OF BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) HAD CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND PLATES WITH CONTAMINATION DURING RECEPTION. 5 OUT OF 1120 PLATES SHOW THE DEFECT.
IT WAS REPORTED THAT 5 PLATES OF BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) HAD CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND PLATES WITH CONTAMINATION DURING RECEPTION. 5 OUT OF 1120 PLATES SHOW THE DEFECT.
IT WAS REPORTED THAT 5 PLATES OF BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) HAD CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND PLATES WITH CONTAMINATION DURING RECEPTION. 5 OUT OF 1120 PLATES SHOW THE DEFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1743914 | BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON DICKINSON GMBH | 1216483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |