PLATE CHOCO GC AG W/ISOVITALEX 90MM 20
Report
- Report Number
- 9680577-2021-00063
- Event Type
- Malfunction
- Date Received
- October 19, 2021
- Date of Event
- September 21, 2021
- Report Date
- December 20, 2021
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSO
- PMA / PMN Number
- K945569
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT 130 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 WAS ONE SIMILAR COMPLAINT REGISTERED. HOWEVER, 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. STERILIZATION RECORD REVIEW: THE MEDIUM ITSELF IS HEAT STERILIZED. HOWEVER, THIS PRODUCT IS FILLED UNDER ASEPTIC CONDITIONS. SINCE A 100 % CONTROL FOR STERILITY IS NOT POSSIBLE A REPRESENTATIVE SAMPLING IS DONE BY THE QC DEPARTMENT. LOT NO. 1211473 COMPLIED TO OUR INTERNAL ACCEPTANCE QUALITY LIMIT (AQL) FOR STERILITY. SAMPLE ANALYSIS: PICTURE SAMPLE WAS PROVIDED SHOWING CONTAMINATION IN THE PLATE. 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. NEITHER A TREND NOR A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. H3 OTHER TEXT : SEE H10.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. 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 BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT CATALOG NUMBER 221240 WHICH IS A CLASS II, 510(K) EXEMPT DEVICE.
IT WAS REPORTED THAT WHILE USING 130 PLATE CHOCO GC AG W/ISOVITALEX 90MM 20 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE QUANTITY OF PLATES DETECTED CONTAMINATED WITH MOLD IS 130 OUT OF 1200."
IT WAS REPORTED THAT WHILE USING 130 PLATE CHOCO GC AG W/ISOVITALEX 90MM 20 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE QUANTITY OF PLATES DETECTED CONTAMINATED WITH MOLD IS 130 OUT OF 1200."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1557944 | PLATE CHOCO GC AG W/ISOVITALEX 90MM 20 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY EXCLUDING MUELLER HINTON | JSO | BECTON DICKINSON GMBH | 1211473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |