BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 15963173 · Received December 12, 2022

    Report

    Report Number
    9616656-2022-01349
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    January 1, 2022
    Report Date
    February 3, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 04-JAN-2023. H6: INVESTIGATION SUMMARY SIX OPEN 30G X 8MM AUTOSHIELD DUO SAMPLES FROM LOT. NO. 2040953 ALONG WITH ONE OPEN 30G X 8MM AUTOSHIELD DUO FROM LOT. NO. 2074948, CAT. NO. 329608 WERE RETURNED. VISUAL EXAMINATION WAS CARRIED OUT ON ALL RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ALL SEVEN SAMPLES. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO PEN NEEDLE BREAKS WHEN UNSCREWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: SINCE THE BEGINNING OF THE YEAR, SHE HAS NOTICED THAT THE NEEDLE BREAKS OFF WHEN IT IS SCREWED ON THROUGH THE RUBBER STOPPER. AT FIRST, SHE THOUGHT IT WAS HER FAULT, BUT LATELY IT HAS BECOME MORE FREQUENT, EVEN THOUGH SHE EXPLICITLY MAKES SURE THAT SHE PUTS THE PEN NEEDLE ON THE PEN CORRECTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO PEN NEEDLE BREAKS WHEN UNSCREWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: SINCE THE BEGINNING OF THE YEAR, SHE HAS NOTICED THAT THE NEEDLE BREAKS OFF WHEN IT IS SCREWED ON THROUGH THE RUBBER STOPPER. AT FIRST, SHE THOUGHT IT WAS HER FAULT, BUT LATELY IT HAS BECOME MORE FREQUENT, EVEN THOUGH SHE EXPLICITLY MAKES SURE THAT SHE PUTS THE PEN NEEDLE ON THE PEN CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230130 BD AUTOSHIELD¿ DUO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2074948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown