BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 17659017 · Received August 31, 2023

    Report

    Report Number
    9680577-2023-00038
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 25, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3150143. D4. MEDICAL DEVICE EXPIRATION DATE: 04-SEP-2023. H4. DEVICE MANUFACTURE DATE: 30-MAY-2023. D4. MEDICAL DEVICE LOT#: 3171798. D4. MEDICAL DEVICE EXPIRATION DATE: 26-SEP-2023. H4. DEVICE MANUFACTURE DATE: 20-JUNE-2023. INITIAL REPORTER PHONE: (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT 8755733 AGAINST BD COLUMBIA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254071, LOT NUMBERS 3150143 AND 3171798 WITH RESPECT TO MEDIA FALLOUT, AGAR SHRINKAGE AND CONTAMINATION. EVENT DESCRIPTION: THE CUSTOMER REPORTED THAT AGAR DRIED UP, FELL OUT OF PLATE INTO THE LID AND IS CONTAMINATED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED, AND A TREND REGARDING THE NUMBER OF MEDIA FALLOUT COMPLAINTS OVER THE PAST MONTHS HAS BEEN OBSERVED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. SAMPLE ANALYSIS: THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION COULD BE DETECTED. RETURN SAMPLES WERE NOT PROVIDED; HOWEVER, PICTURES ILLUSTRATING THE MEDIA FALLOUT AND THE RESULTING CONTAMINATION HAVE BEEN SHARED. EVALUATION RESULTS: A TREND HAS BEEN IDENTIFIED FOR MEDIA FALLOUT. NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME; HOWEVER, CONTINUOUS IMPROVEMENT OPPORTUNITIES ARE BEING REVIEWED FOR THIS DEFECT. PLATED MEDIA FORMULATIONS CONSIST OF APPROXIMATELY 95% WATER. THEREFORE, IT IS EXPECTED THAT THERE WILL BE SOME NORMAL WATER LOSS DURING THE STORAGE AND USAGE OF THE PRODUCT, RESULTING IN SUBJACENT BUBBLES AND EVENTUALLY IN MEDIA FALLOUT. THE SEVERITY OF THIS ISSUE CAN BE FURTHER INCREASED BY TEMPERATURE EXCURSIONS DURING THE TRANSPORT/STORAGE OF THE PRODUCT. MOREOVER, UNCAREFUL HANDLING OF THE BOXES DURING THE TRANSPORT/STORAGE CAN LEAD TO MEDIA FALLOUT AND CONTAMINATION ON THE AGAR THAT HAS FALLEN OUT. HOWEVER, A ROOT CAUSE COULD NOT BE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE PROVIDED PICTURES AND THE REPORT THE COMPLAINT WAS CONFIRMED FOR MEDIA FALLOUT, AGAR SHRINKAGE AND CONTAMINATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE COMPLAINT WAS REGISTERED IN OUR DATABASE AND BD WILL CONTINUE TO MONITOR INCOMING REPORTS FOR THIS FAILURE MODE. WE ARE SORRY FOR THE INCONVENIENCE. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: D.1. UNIQUE IDENTIFIER (UDI) # (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLATE COLUMBIA AG 5PRCT SB 90MM CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AGAR DRIED UP, FALLEN OFF AND CONTAMINATED. *PHOTO ATTACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLATE COLUMBIA AG 5PRCT SB 90MM CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AGAR DRIED UP, FALLEN OFF AND CONTAMINATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349890 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 3171798

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown