PLATE COL CNA AG 5% SB IMPROVED 120EA
Report
- Report Number
- 9680577-2021-00013
- Event Type
- Malfunction
- Date Received
- April 6, 2021
- Date of Event
- March 12, 2021
- Report Date
- October 21, 2021
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSI
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD & COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD - I PLATE¿ CATALOG NUMBER 299818 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE.
H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, IMPROVED II, CATALOG NUMBER 257306, LOT NUMBER 1029958. EVENT DESCRIPTION: IT WAS REPORTED THAT STAPH. AUREUS WOULD NOT ON THE MEDIUM. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED. DURING THIS PERIOD, NO FURTHER COMPLAINTS WERE REPORTED FOR THIS PRODUCT FOR PERFORMANCE RELATED ISSUES. THEREFORE, A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD REVIEW DID NOT SHOW ANY DISCREPANCIES. SAMPLE ANALYSIS: PICTURE SAMPLE WAS PROVIDED SHOWING GROWN COLONIES ON THE PLATE. AN ANALYSIS OF GROWTH PROMOTION FOR THE MEDIA WAS PERFORMED ON RETENTION SAMPLES FOR BATCH 1029958: STAPH. AUREUS ATCC 25923 AND STAPH. AUREUS VIVANTES 15135 RESULTED IN EXCELLENT GROWTH WITH WHITE COLONIES AFTER AN INCUBATION OF 24 HOURS AT 36 ± 1°C IN A CO²-ATMOSPHERE. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. THE QC PERFORMANCE TEST WAS PERFORMED WITHOUT ANY DEVIATIONS. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE REPORTS, AND THE QC PERFORMANCE TEST THE COMPLAINT WAS NOT CONFIRMED. 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.
IT WAS REPORTED THAT WHILE USING PLATE COL CNA AG 5% SB IMPROVED 120EA ATYPICAL GROWTH 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: " SAUR DOES NOT GROW PROPERLY ON CNA PLATE BATCH NUMBER 1029958 QUESTION PENDING IF THIS WAS ON ATCC STRAIN DURING QC OR WITH PATIENT MATERIAL"
IT WAS REPORTED THAT WHILE USING PLATE COL CNA AG 5% SB IMPROVED 120EA ATYPICAL GROWTH 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: " SAUR DOES NOT GROW PROPERLY ON CNA PLATE BATCH NUMBER 1029958 QUESTION PENDING IF THIS WAS ON ATCC STRAIN DURING QC OR WITH PATIENT MATERIAL".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522137 | PLATE COL CNA AG 5% SB IMPROVED 120EA | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON DICKINSON GMBH | 1029958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |