BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 5MM

    MDR report key: 11758795 · Received May 2, 2021

    Report

    Report Number
    9616656-2021-00460
    Event Type
    Malfunction
    Date Received
    May 2, 2021
    Date of Event
    April 5, 2021
    Report Date
    May 25, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE OPEN 31G X 5MM PEN NEEDLE SAMPLE AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 0203811, CAT. NO.320129. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND DAMAGE TO THE COVER WAS OBSERVED. 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 A JAM ON THE MACHINE DURING THE MANUFACTURING PROCESS. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 31GA 5MM EXPERIENCED MOLDING DEFECT -SHORT SHOTS ON COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, WHEN REMOVING THE INNER SHIELD, THE HUB WAS FOUND TO BE DAMAGED/DEFORMED.

    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 THE PEN NDL 31GA 5MM EXPERIENCED MOLDING DEFECT -SHORT SHOTS ON COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, WHEN REMOVING THE INNER SHIELD, THE HUB WAS FOUND TO BE DAMAGED/DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654978 PEN NDL 31GA 5MM PEN NEEDLE FMI BECTON DICKINSON AND CO. 0203811

    Patients

    Seq Age Sex Outcome Treatment
    1