BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), PLATE, 90 MM X 120
Report
- Report Number
- 9680577-2022-00042
- Event Type
- Malfunction
- Date Received
- March 29, 2022
- Date of Event
- February 28, 2022
- Report Date
- June 26, 2022
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSO
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 2212340 WITH 510(K) K945569. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6: EVENT DESCRIPTION: IT WAS REPORTED THAT UPON RECEIPT OF THE DELIVERY, MANY PLATES WERE BROKEN AND SOME PLATES WERE CONTAMINATED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY OF THE AFFECTED BATCH WAS REVIEWED. THERE WERE NO SIMILAR COMPLAINTS REGISTERED. THEREFORE, A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) 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. THERE WAS NEITHER A CONTAMINATION NOR BROKEN PLATES. 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. 2018457 COMPLIED TO OUR INTERNAL ACCEPTANCE QUALITY LIMIT (AQL) FOR STERILITY. SAMPLE ANALYSIS: PICTURE SAMPLE WAS PROVIDED SHOWING CONTAMINATION IN THE PLATE. FURTHERMORE, BROKEN PLATES WERE VISIBLE. RETAIN SAMPLES WERE ANALYZED. NO CONTAMINATION AND BROKEN PLATES WERE DETECTED. INVESTIGATION RESULTS AND 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. BROKEN PLATES MAY BE AN OUTCOME OF THE TRANSPORT OF THE PLATES. CONTAMINATED PLATES MAY BE A RESULT OF THE WRONG TRANSPORT. BASED ON THE INTERNAL INVESTIGATION AND THE PROVIDED PICTURES, THE COMPLAINT WAS CONFIRMED FOR CONTAMINATION AND BROKEN PLATES. NEITHER A TREND NOR A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED.
IT WAS REPORTED THAT PRIOR TO USE, BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), PLATE, 90 MM X 120 WERE CONTAMINATED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON RECEIPT OF THE DELIVERY, MANY BOXES ... WERE CONTAMINATED.
IT WAS REPORTED THAT PRIOR TO USE, BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), PLATE, 90 MM X 120 WERE CONTAMINATED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON RECEIPT OF THE DELIVERY, MANY BOXES ... WERE CONTAMINATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25061 | BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), PLATE, 90 MM X 120 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON | JSO | BECTON DICKINSON GMBH | 2018457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |