BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLATELET ANAEROBIC/F CULTURE VIALS

    MDR report key: 12870008 · Received November 24, 2021

    Report

    Report Number
    2647876-2021-00298
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 29, 2021
    Report Date
    January 19, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MZC
    PMA / PMN Number
    BK180211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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

    H.6. INVESTIGATION: CUSTOMER REPORTED ONE CASE WITHOUT CARTON LABEL ID. PHOTOS WITHOUT THE CARTON LABEL WERE PROVIDED. BD WAS UNABLE TO REPRODUCE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED FOR PRESENCE OF CARTON LABEL. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS CONFIRMED BASED ON PHOTOS PROVIDED BY THE CUSTOMER. TECHNICAL ASSESSMENT WAS PERFORMED BY THE ENGINEERING DEPARTMENT TO DETERMINE IF THE LABELER ACCRAPLY CARTON CASE HAD MECHANICAL ISSUES AND/OR BREAKDOWNS DURING THE PACKAGING PROCESS OF AFOREMENTIONED BATCH. THE ENGINEERING INVESTIGATION REVEALED THAT PREVENTIVE MAINTENANCE TO THE ACCRAPLY CARTON CASE MACHINE WAS COMPLETED ON TIME AS SCHEDULED. UPON EVALUATION OF BREAKDOWNS / INCIDENTS REPORTS, THERE WERE NO CARTON LABEL APPLICATION ISSUES REPORTED. THERE ARE ENGINEERING CONTROLS TO AVOID THIS TYPE OF DEFECT AND AS A PREVENTIVE ACTION THE MACHINE WAS VERIFIED, AND IT WAS FOUND WORKING AS EXPECTED. NO TREND HAS BEEN IDENTIFIED FOR THIS TYPE OF DEFECT. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, 50 BD BACTEC¿ PLATELET ANAEROBIC/F CULTURE VIALS HAD NO LABEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND 1 BOX OF BD PLATELET ANAEROBIC MEDIA HAD NOT LABEL ON BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, 50 BD BACTEC¿ PLATELET ANAEROBIC/F CULTURE VIALS HAD NO LABEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND 1 BOX OF BD PLATELET ANAEROBIC MEDIA HAD NOT LABEL ON BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770517 BD BACTEC¿ PLATELET ANAEROBIC/F CULTURE VIALS SYSTEM, DETECTION, BACTERIAL, FOR PLATELET TRANSFUSION PRODUCTS MZC BECTON DICKINSON CARIBE LTD. 1184767

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown