BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 15694553 · Received October 29, 2022

    Report

    Report Number
    9616656-2022-01161
    Event Type
    Malfunction
    Date Received
    October 29, 2022
    Date of Event
    October 5, 2022
    Report Date
    December 6, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE OPEN 30G X 5MM SAFETY PEN NEEDLE SAMPLE AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 2040002, CAT. NO. 329705. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND IT WAS OBSERVED THAT THE SAFETY PEN NEEDLE WAS NOT ACTIVATED AND THE PATIENT END OF CANNULA WAS EXPOSED. 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. THIS ISSUE MOST LIKELY OCCURRED DUE TO AN INCONSISTENT APPLICATION OF GEL DURING THE ASSEMBLY PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE THE SAFETY SHIELD DIDN'T WORK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AFTER INJECTION DURING PRODUCT DEMONSTRATION, THE SAFETY MECHANISM WAS NOT ACTIVATED, WITH THE NEEDLE EXPOSED. DANGEROUS, THE NEEDLE WAS COVERED BY USING THE OUTER COVER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE THE SAFETY SHIELD DIDN'T WORK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AFTER INJECTION DURING PRODUCT DEMONSTRATION, THE SAFETY MECHANISM WAS NOT ACTIVATED, WITH THE NEEDLE EXPOSED. DANGEROUS, THE NEEDLE WAS COVERED BY USING THE OUTER COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2880578 BD AUTOSHIELD¿ DUO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2040002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown