BD BBL¿ MACCONKEY II AGAR
Report
- Report Number
- 9680577-2024-00023
- Event Type
- Malfunction
- Date Received
- August 2, 2024
- Date of Event
- July 4, 2024
- Report Date
- August 13, 2024
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: THIS MEMO IS TO UPDATE THE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) AGAINST MACCONKEY II AGAR, CATALOG NUMBER: 254078, LOT NUMBER: 4123008 WITH RESPECT TO A PERFORMANCE ISSUE. EVENT DESCRIPTION: CUSTOMER REPORTS THAT THEY CANNOT USE THEIR MIXED CULTURE PLATES BECAUSE THEY CANNOT RECOGNIZE THE COLONIES, BECAUSE THE GROWTH OF ONE COLONY MASKS THE ENTIRE PLATE WITH AN "OILY HALO". COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY FOR THE PAST 12 MONTHS WAS REVIEWED, AND NO SIMILAR COMPLAINT WAS IDENTIFIED FOR LOT NUMBER: 4123008. A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED. NO DEVIATIONS FROM THE VALIDATED PROCESS PARAMETERS WERE DETECTED. RELEASE TESTING BY THE QC DEPARTMENT WAS SATISFACTORY. INITIAL SAMPLE ANALYSIS: WITHIN THE COMPLAINT INVESTIGATION, RETAINMENT SAMPLES OF LOT: 4123008 WERE ANALYZED ACCORDING TO THE QUALITY CONTROL RELEASE PARAMETERS. ALL TESTED STRAINS GREW ACCORDING TO THE SPECIFICATION. PLATES WERE INCUBATED AT 35-37°C FOR 18-24H. ALL STRAINS SHOWED GOOD GROWTH ACCORDING TO OUR SPECIFICATIONS. RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE SAMPLES, PROVIDED BY THE CUSTOMER, SHOW PLATES OF MACCONKEY II AGAR WITH GROWTH OF ROSE TO PINK AND ADDITIONALLY COLORLESS COLONIES WITH HALOS. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. NO DEVIATION COULD BE FOUND DURING THE QC RELEASE PERFORMANCE TEST AND THE PERFORMANCE TEST ON THE RETAIN SAMPLES. IN ADDITION, NO OTHER CUSTOMER HAS RAISED A SIMILAR COMPLAINT FOR THIS LOT NUMBER. WE CONSIDER THE OCCURRENCE A SINGLE EVENT. SINCE NO TREND WAS IDENTIFIED, NO CORRECTIVE PREVENTIVE ACTION WILL BE IMPLEMENTED THIS TIME. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. ALL THE RELEASE TESTING WAS SATISFACTORY. FURTHERMORE, UPON EVALUATION OF RETAIN SAMPLES WE CANNOT CONFIRM THE COMPLAINT FOR PERFORMANCE ISSUE. RESULTS OF GROWTH PROMOTION TESTS WERE SATISFACTORY. A DEFINITE ROOT CAUSE HAS NOT BEEN ESTABLISHED.
E1. INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD BBL¿ MACCONKEY II AGAR AN UNSPECIFIED NUMBER OF PLATES HAD AN ATYPICAL OILY HALO AROUND THE GROWING MICROORGANISM. THE OILY HALO MASKED THE PLATE AND MADE IT DIFFICULT TO DETERMINE IF THERE WAS MIXED GROWTH. IDENTIFICATION WITH BRUKER MALDI-TOF WAS USED TO CONFIRM THE ORGANISM. THE NEED FOR CONFIRMATION TESTING DELAYED THE TIME TO FINAL RESULT REPORTING. THERE WAS NO FURTHER HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING BD BBL¿ MACCONKEY II AGAR AN UNSPECIFIED NUMBER OF PLATES HAD AN ATYPICAL OILY HALO AROUND THE GROWING MICROORGANISM. THE OILY HALO MASKED THE PLATE AND MADE IT DIFFICULT TO DETERMINE IF THERE WAS MIXED GROWTH. IDENTIFICATION WITH BRUKER MALDI-TOF WAS USED TO CONFIRM THE ORGANISM. THE NEED FOR CONFIRMATION TESTING DELAYED THE TIME TO FINAL RESULT REPORTING. THERE WAS NO FURTHER HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1215999 | BD BBL¿ MACCONKEY II AGAR | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON DICKINSON GMBH | 4123008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |