BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    MDR report key: 8971716 · Received September 6, 2019

    Report

    Report Number
    9616656-2019-00839
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 15, 2019
    Report Date
    October 23, 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 SUMMARY: TWO OPEN 30G X 5MM SAFETY PEN NEEDLES WERE RETURNED FROM LOT. NO. 8170731, CAT. NO. 329505. VISUAL EXAMINATION WAS CARRIED OUT ON THE TWO OPENED SAMPLES IT WAS OBSERVED THAT BOTH SAMPLES WERE RETURNED ACTIVATED. 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. CONCLUSION; AS THE SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHIELD ATTACHMENT ISSUES OCCURRED BEFORE USE WITH A PEN NEEDLE AUTOSHIELD DUO 30GX5MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING PRIMING,IT'S NOTICED THAT 1. THE SAFETY NEEDLE CAP ON THE PATIENT'S END IS LOCKED AND CANNOT BE USED.THIS PHENOMENON HAS OCCURRED 3-4 TIMES 2. THE SAFETY HELMET AT THE END OF THE INJECTION PEN IS UNPACKED AFTER OPENING THE PACKAGE AND CANNOT BE USED. THIS PHENOMENON HAPPENS ONCE." 4 OCCURRENCES WERE REPORTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHIELD ATTACHMENT ISSUES OCCURRED BEFORE USE WITH A PEN NEEDLE AUTOSHIELD DUO 30GX5MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING PRIMING,IT'S NOTICED THAT THE SAFETY NEEDLE CAP ON THE PATIENT'S END IS LOCKED AND CANNOT BE USED. THIS PHENOMENON HAS OCCURRED 3-4 TIMES. THE SAFETY HELMET AT THE END OF THE INJECTION PEN IS UNPACKED AFTER OPENING THE PACKAGE AND CANNOT BE USED. THIS PHENOMENON HAPPENS ONCE." 4 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764694 PEN NEEDLE AUTOSHIELD DUO 30GX5MM PEN NEEDLE FMI BECTON DICKINSON AND CO. 8170731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other