BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2/FLU FOR BD MAX SYSTEM

    MDR report key: 11667667 · Received April 14, 2021

    Report

    Report Number
    1119779-2021-00663
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EUA#: (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR INCORRECT PACKOUT OF SAMPLE BUFFER TUBES IN THE KIT BD SARS COV-2/FLU (REF #445011) FROM LOT 0338482 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETENTION MATERIAL INSPECTION, REVIEW OF CUSTOMER¿S PICTURES AND VERIFICATION OF COMPLAINTS HISTORY. CUSTOMER REPORTED THAT WHEN OPENING A BD SARS COV-2/FLU KIT, HE NOTICED A MIX OF SBT IN A CLIP. INDEED, THE CLIP WAS CONTAINING SBT FROM BOTH BD SARS COV-2/FLU AND BD MAX¿ TNA-3 ASSAYS. REVIEW OF THE MANUFACTURING RECORDS OF BD SARS COV-2/FLU INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF THE BD SARS-COV-2/FLU KIT LOT 0338482 WAS INSPECTED. THE KIT BOXES EACH CONTAINED 2 CLIPS OF 12 SBT FROM SARS COV-2/FLU ONLY AS EXPECTED. CUSTOMER PROVIDED THREE PICTURES FOR INVESTIGATION. THE FIRST PICTURE SHOWS THAT THE KIT WAS CORRESPONDING TO BD SARS-COV-2/FLU FOR BD MAX SYSTEM FROM LOT 0338482. THE TWO OTHER PICTURES SHOW A CLIP CONTAINING SBT FROM 2 DIFFERENT PRODUCTS. INDEED, THE CLIP INCLUDED 6 SBT WITH A YELLOW COLOR ON THE LABEL, CORRESPONDING TO SARS COV-2/FLU SBT FROM LOT 0344809, BUT ALSO CONTAINED 6 SBT WITH A BROWN COLOR ON THE LABEL, CORRESPONDING TO BD MAX EXK TNA-3 SBT FROM LOT 0332956. REVIEW OF INTERNAL DATA SHOWED THAT THE BD MAX¿ EXK¿ TNA-3 SBT FROM LOT 0332956 WERE LABELLED ON 2020-12-16 AND 2020-12-17. ON 2020-12-17, LABELLING OF THE BD MAX¿ EXK¿ TNA-3 SBT WAS PAUSED TO SWITCH TO THE LABELLING OF THE BD SARS-COV-2/FLU SBT FROM LOT 0344809, USING THE SAME EQUIPMENTS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR INCORRECT PACKOUT OF SAMPLE BUFFER TUBES IN THE BD MAX PRODUCT KITS. BD CONFIRMS THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MIX OF PRODUCT WITH A BD SARS-COV-2/FLU FOR BD MAX SYSTEM. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SBT IN KIT WAS A MIX OF SARS/FLU AND TNA-3, CUSTOMER HAS TOSSED PRODUCT, SINCE THEY ARE AFRAID IF THIS IS MISSLABELLING OR SIMPLY A MIX OF PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MIX OF PRODUCT WITH A BD SARS-COV-2/FLU FOR BD MAX SYSTEM. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SBT IN KIT WAS A MIX OF SARS/FLU AND TNA-3, CUSTOMER HAS TOSSED PRODUCT, SINCE THEY ARE AFRAID IF THIS IS MISSLABELLING OR SIMPLY A MIX OF PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562891 BD SARS-COV-2/FLU FOR BD MAX SYSTEM BD SARS-COV-2/FLU FOR BD MAX SYSTEM QJR BECTON, DICKINSON & CO. (SPARKS) 0338482

    Patients

    Seq Age Sex Outcome Treatment
    1