PLATE BBL CHROMAGAR ORIENTATION 90MM
Report
- Report Number
- 9680577-2024-00038
- Event Type
- Malfunction
- Date Received
- November 19, 2024
- Date of Event
- November 4, 2024
- Report Date
- December 2, 2024
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSH
- UDI-DI
- 30382902541074
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY THIS MEMO IS TO UPDATE THE FINDINGS ON YOUR RECENT COMPLAINT PR (B)(4) AGAINST BD BBL CHROMAGAR ORIENTATION AGAR, CATALOG NUMBER 254107, LOT NUMBER 4198850 WITH RESPECT TO A PERFORMANCE ISSUE. EVENT DESCRIPTION: THE CUSTOMER COMPLAINED ON UNEXPECTED CHROMOGENIC COLOR OF E. COLI COLONIES. ALL COLONIES WERE TRANSPARENT AND NOT BLUE AS TYPICAL TO E. COLI. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY OF THE LAST 12 MONTHS WAS REVIEWED, AND NO SIMILAR PERFORMANCE COMPLAINT THAT DESCRIBES TRANSPARENT INSTEAD OF BLUE COLONIES OF E. COLI WAS IDENTIFIED FOR THIS CATALOG NUMBER. 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 4198850 WERE ANALYZED ACCORDING TO THE QUALITY CONTROL RELEASE PARAMETERS. ALL TESTED STRAINS GREW ACCORDING TO THE SPECIFICATION, AFTER INCUBATION AEROBICALLY FOR 18-24 H AT 35-37 °C IN THE DARK. E. COLI ATCC 25922 TEST STRAIN SHOWED ROSE TO PINK COLONIES, AS DESCRIBED IN THE CERTIFICATE OF ANALYSIS (COA). RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. A PICTURE SAMPLE, PROVIDED BY THE CUSTOMER, SHOWS A PLATE OF LOT 4198850 WITH GROWTH OF WHITE COLONIES. 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. PLEASE TAKE CARE THAT THE CHROMAGAR ORIENTATION PLATES SHOULD BE STORED IN THE DARK, AS THIS MAY HAVE AN INFLUENCE ON THE RESULT. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION ON RETAIN SAMPLES, THE COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE ISSUE. ALL PREPARED MEDIA MUST BE STORED IN THE DARK. IF EXPOSED TO ARTIFICIAL LIGHT, SUNLIGHT, OR UV LIGHT FOR A LONGER TIME, THE PERFORMANCE OF ALL MEDIA MAY BE REDUCED. SEVERAL MEDIA, SUCH AS CHROMOGENIC MEDIA, ARE ESPECIALLY SENSITIVE TO STRONG ILLUMINATION BEFORE AND DURING INCUBATION. BD REGRETS THE INCONVENIENCES YOU EXPERIENCED AND WILL CONTINUE TO MONITOR SIMILAR INCOMING COMPLAINTS.
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 PLATE BBL CHROMAGAR ORIENTATION 90MM AN UNSPECIFIED NUMBER OF PLATES EXHIBITED AN UNEXPECTED CHROMOGENIC COLOR OF E. COLI COLONIES. INSTEAD OF BEING THE EXPECTED BLUE COLOR THE COLONIES WERE TRANSPARENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING PLATE BBL CHROMAGAR ORIENTATION 90 MM AN UNSPECIFIED NUMBER OF PLATES EXHIBITED AN UNEXPECTED CHROMOGENIC COLOR OF E. COLI COLONIES. INSTEAD OF BEING THE EXPECTED BLUE COLOR THE COLONIES WERE TRANSPARENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1307524 | PLATE BBL CHROMAGAR ORIENTATION 90MM | CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL | JSH | BECTON DICKINSON GMBH | 4198850 | 30382902541074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |