BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 12739617 · Received November 2, 2021

    Report

    Report Number
    9680577-2021-00068
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 5, 2021
    Report Date
    December 6, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A CONTAMINATION OF LOT 1176770 WITH A FUNGI AND LOT 1187925 WITH FILOBASIDIUM UNIGUTTULATUM WAS REPORTED. THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. NO SIMILAR COMPLAINTS WERE REGISTERED FOR THE COMPLAINT BATCH. HOWEVER, ADDITIONAL CONTAMINATION COMPLAINTS WITH SIMILAR ORGANISMS WERE RECEIVED FOR THE COMPLAINT PRODUCT. THEREFORE, A TREND COULD BE IDENTIFIED. THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES FROM VALIDATED PRODUCTION PROCESSES. HOWEVER, QC RELEASE TESTING OF ONE SUBLOT EACH FOR LOT 1176770 AND LOT 1187925 SHOWED SUBLIMINAL CONTAMINATION. THE INTERNAL ACCEPTANCE QUALITY LIMIT (AQL) FOR STERILITY WAS NOT VIOLATED. RETURN SAMPLES AND PICTURES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE SAMPLES WERE PROVIDED BY THE CUSTOMER SHOWING PLATES CONTAMINATED BY A SINGULAR MOLD COLONY AND SEVERAL PLATES SHOWING GROWTH OF A YEAST LIKE MICROORGANISM. RETAIN SAMPLES OF LOTS 1176770 AND 1187925 WERE ANALYZED AND SHOWED NO SIGN OF CONTAMINATION. BASED ON THE INTERNAL INVESTIGATION AND THE PICTURE SAMPLES PROVIDED, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. IN ADDITION, A COMPLAINT TREND FOR CATALOG NUMBER 254071 WAS IDENTIFIED. THEREFORE, AN INTERNAL TEAM WAS FORMED FOR INVESTIGATION PURPOSES. A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1176770. MEDICAL DEVICE EXPIRATION DATE: 2021-09-30. DEVICE MANUFACTURE DATE: 2021-06-25. MEDICAL DEVICE LOT #: 1187925. MEDICAL DEVICE EXPIRATION DATE: 2021-10-12. DEVICE MANUFACTURE DATE: 2021-07-06. 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 AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221263 WHICH IS A PREAMENDMENT DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 6 PLATES COLUMBIA AG 5PRCT SB 90MM CONTAMINATION 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: "CONTAMINATED PLATES, FUNGI (LOT 1176770 )."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 6 PLATES COLUMBIA AG 5PRCT SB 90MM CONTAMINATION 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: "CONTAMINATED PLATES, FUNGI (LOT 1176770 )".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639141 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown