BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 14055370 · Received April 8, 2022

    Report

    Report Number
    9680577-2022-00052
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 28, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    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

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THAT 150 PLATES WOULD HAVE SHOWN CONTAMINATION. THE COMPLAINT TRENDS WERE REVIEWED AND SIMILAR COMPLAINTS WERE FOUND FOR THIS LOT NUMBER. THEREFORE, A MRB (MATERIAL REVIEW BOARD) WAS PERFORMED AND THIS ISSUE WILL BE INVESTIGATED WITHIN A CAPA (CORRECTIVE AND PREVENTIVE ACTION) 4344556. THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. PICTURES WERE PROVIDED SHOWING THE REPORTED CONTAMINATION. THE RETENTION SAMPLES WERE REVIEWED AND THE PLATES WERE FOUND TO BE WITHOUT DEVIATION. AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. PLEASE NOTE THAT THIS PRODUCT DOES NOT HAVE AN SAL CLAIM. IT IS FILLED ASEPTICALLY, THEREFORE AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. WE ONLY RELEASE PRODUCT BATCHES TO THE MARKET WITH AN AQL (ACCEPTABLE QUALITY LEVEL) = 1.5. ALTHOUGH THIS CONTAMINATION LEVEL IS VERY LOW, WE CANNOT COMPLETELY EXCLUDE THAT A CUSTOMER MAY RECEIVE A CONTAMINATED PLATE. AS SEVERAL COMPLAINTS WERE REPORTED FOR THIS PRODUCT LOT NUMBER REGARDING CONTAMINATION, A MRB ((B)(4)) AND CAPA (# 4344556) WERE CREATED FOR FURTHER EVALUATION. THE ROOT CAUSE INVESTIGATION IS CURRENTLY ONGOING WITHIN CAPA 4344556. BASED UPON OUR INVESTIGATION THE COMPLAINT WAS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 150 BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD PLATES WERE FOUND CONTAMINATED, AND STAPHYLOCOCCUS EQUORUM WAS IDENTIFIED AFTER MAKING A MALDI-TOF ANALYSIS. THERE WAS NO REPORT OF ADVERSE IMPACT TO THE USER OR PATIENT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: "MORE THAN 30% OF THE BATCH 2033567 IS CONTAMINATED. I ASKED THE CUSTOMER IF A MALDI-TOF COULD BE MADE. STAPHYLOCOCCUS EQUORUM HAS BEEN IDENTIFIED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 150 BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD PLATES WERE FOUND CONTAMINATED, AND STAPHYLOCOCCUS EQUORUM WAS IDENTIFIED AFTER MAKING A MALDI-TOF ANALYSIS. THERE WAS NO REPORT OF ADVERSE IMPACT TO THE USER OR PATIENT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: "MORE THAN 30% OF THE BATCH 2033567 IS CONTAMINATED. I ASKED THE CUSTOMER IF A MALDI-TOF COULD BE MADE. STAPHYLOCCUS EQUORUM HAS BEEN IDENTIFIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150238 BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 2033567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown