BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR
Report
- Report Number
- 9680577-2021-00087
- Event Type
- Malfunction
- Date Received
- November 29, 2021
- Date of Event
- November 1, 2021
- Report Date
- January 4, 2022
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LG
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT 3885767 AGAINST BBL¿ CHROMAGAR¿ ORIENTATION MEDIUM, CATALOG NUMBER 257481, LOT NUMBER 1223071. EVENT DESCRIPTION: IT WAS REPORTED THAT CONTAMINATION WAS DETECTED IN 13 BOXES WITH PLATES. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED AND NO SIMILAR COMPLAINTS WERE RECORDED FOR THE RESPECTIVE BATCH. HOWEVER, SINCE THIS PRODUCT IS FILLED ASEPTICALLY WITH AN AQL FOR STERILITY OF 1.5 RARE CONTAMINATION EVENTS ARE TO BE EXPECTED. THEREFORE A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BHR WAS REVIEWED. NO DEVIATION FROM THE VALIDATED PROCESSES AND PARAMETERS WERE REGISTERED. SAMPLE ANALYSIS: THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION COULD BE DETECTED. PICTURE SAMPLE WAS PROVIDED SHOWING CONTAMINATED PLATES. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. THIS PRODUCT DOES NOT HAVE AN SAL (STERILITY ASSURANCE LEVEL) CLAIM. IT IS FILLED ASEPTICALLY, THEREFORE AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. PLEASE NOTE THAT THE VALID STANDARD FOR THESE PRODUCTS IS DIN EN 12322 "IN VITRO DIAGNOSTIC MEDICAL DEVICES - CULTURE MEDIA FOR MICROBIOLOGY". ACCORDING TO THIS STANDARD THE CONTAMINATION RATE FOR EACH PRODUCT LOT MUST NOT EXCEED 4.9%. BASED UPON OUR CONTINUOUS MONITORING, WE DERIVE A CONTAMINATION RATE THAT FALLS BELOW THIS SPECIFIED VALUE. ACCORDING TO OUR HIGH QUALITY STANDARD, WE ONLY RELEASE PRODUCT BATCHES TO THE MARKET WITH AN AQL (ACCEPTABLE QUALITY LEVEL) = 1.5. ALTHOUGH THIS CONTAMINATION LEVEL IS VERY LOW, WE CANNOT COMPLETELY EXCLUDE THAT A CUSTOMER MAY RECEIVE CONTAMINATED PLATES. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION AND AND PROVIDED PICTURES, THE COMPLAINT WAS CONFIRMED FOR CONTAMINATION. WE WOULD SUGGEST TO SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE 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.
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 13 PLATES OF BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATED PLATES WITH MOULDS GROWING. CONTAMINATED PLATES DETECTED WHEN BOXES OF PLATES WERE OPENED. OUT OF 20 BOXES RECEIVED, 13 BOXES SHOWED CONTAMINATION.
IT WAS REPORTED THAT 13 PLATES OF BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATED PLATES WITH MOULDS GROWING. CONTAMINATED PLATES DETECTED WHEN BOXES OF PLATES WERE OPENED. OUT OF 20 BOXES RECEIVED, 13 BOXES SHOWED CONTAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1779758 | BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR | CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL | JSH | BECTON DICKINSON GMBH | 1223071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |