BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD DUO PEN NEEDLE

    MDR report key: 10638979 · Received October 6, 2020

    Report

    Report Number
    9616656-2020-01005
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-09-30. H6: INVESTIGATION SUMMARY: ONE OPEN 30G X 5MM AUTOSHIELD DUO SAMPLE WAS RETURNED FROM LOT. NO. 9231923, CAT. NO. 329505. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE SAMPLE WAS ACTIVATED UPON RECEIPT. DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO CLOG TEST COULD BE CARRIED OUT. 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. DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO FURTHER INVESTIGATION COULD BE CARRIED OUT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE BD AUTOSHIELD¿ DUO PEN NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "WHEN USING THE PRODUCT, THE PATIENT FOUND NO OBVIOUS ABNORMALITIES IN THE APPEARANCE AND NORMAL USE OF THE PRODUCT, AND THE LEAKAGE OF INSULIN INJECTION OCCURRED. WHEN THE PATIENT WENT TO THE HOSPITAL FOR NEEDLE ALLOCATION AGAIN, THE FEEDBACK WAS GIVEN TO THE DIABETES SPECIALIST NURSE, WHO CONTACTED THE SALESMAN OF THE MANUFACTURER, NURSE SUGGESTED THAT THE QUALITY OF THE NEEDLE WAS ABNORMAL."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE THE BD AUTOSHIELD¿ DUO PEN NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "WHEN USING THE PRODUCT, THE PATIENT FOUND NO OBVIOUS ABNORMALITIES IN THE APPEARANCE AND NORMAL USE OF THE PRODUCT, AND THE LEAKAGE OF INSULIN INJECTION OCCURRED. WHEN THE PATIENT WENT TO THE HOSPITAL FOR NEEDLE ALLOCATION AGAIN, THE FEEDBACK WAS GIVEN TO THE DIABETES SPECIALIST NURSE, WHO CONTACTED THE SALESMAN OF THE MANUFACTURER, NURSE SUGGESTED THAT THE QUALITY OF THE NEEDLE WAS ABNORMAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104507 BD AUTOSHIELD DUO PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 9231923

    Patients

    Seq Age Sex Outcome Treatment
    1 Other