BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 8782208 · Received July 11, 2019

    Report

    Report Number
    9616656-2019-00612
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF A 30G X 5MM AUTOSHIELD DUO SAMPLE WAS RETURNED FROM LOT. NO. 8170731, CAT. NO. 329505. VISUAL EXAMINATION OF THE RETURNED PHOTO WAS CARRIED OUT AND IT WAS OBSERVED THAT THE NEEDLE WAS ATTACHED TO THE PEN AND HAD BROKEN OFF FROM THE AUTOSHIELD DUO. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE PHOTO PROVIDED AND THE FACT NO SAMPLE WAS RETURNED FOR INVESTIGATION THIS CANNOT BE CONFIRMED TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD AUTOSHIELD¿ DUO PEN NEEDLE HAD A RETRACTION ISSUE. THIS WAS DISCOVERED DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT NEEDLE STUCK ON THE INJECTION PENS DURING NEEDLE RETRACTION. NO NEEDLE STICK HARM TO THE END USER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD AUTOSHIELD¿ DUO PEN NEEDLE HAD A RETRACTION ISSUE. THIS WAS DISCOVERED DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT NEEDLE STUCK ON THE INJECTION PENS DURING NEEDLE RETRACTION. NO NEEDLE STICK HARM TO THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576536 BD AUTOSHIELD¿ DUO PEN NEEDLE NEEDLE FMI BECTON DICKINSON AND CO. 8170731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other