BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 14138245 · Received April 18, 2022

    Report

    Report Number
    9616656-2022-00423
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 26, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 05-MAY-2022. H.6. INVESTIGATION: ONE OPEN 30G X 5MM SAFETY PEN NEEDLE WAS RETURNED FROM LOT. NO. 0020507, CAT. NO. 329608. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS THE SAMPLE WAS RETURNED OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO PEN NEEDLE EXPERIENCED THE CANNULA BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ASD TRAINING (NO PATIENTS INVOLVED) THE BACK CANULA BREAKS FROM PEN NEEDLE AND GETS STUCK IN MEMBRANE OF PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO PEN NEEDLE EXPERIENCED THE CANNULA BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ASD TRAINING (NO PATIENTS INVOLVED) THE BACK CANULA BREAKS FROM PEN NEEDLE AND GETS STUCK IN MEMBRANE OF PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606012 BD AUTOSHIELD¿ DUO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0020507

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown