BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11566205 · Received March 24, 2021

    Report

    Report Number
    9616656-2021-00314
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM HP 100 BOX 1200 US CANNULA LENGTH WAS INSUFFICIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320550, BATCH NO: 0203719. IT WAS REPORTED THAT THE CONSUMER FEELS THIS NEEDLE IS SHORTER THAN 320122 AND NEEDLE PINCHES WHEN INSERTED INTO THE INJECTION SITE.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM HP 100 BOX 1200 US CANNULA LENGTH WAS INSUFFICIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320550, BATCH NO: 0203719. IT WAS REPORTED THAT THE CONSUMER FEELS THIS NEEDLE IS SHORTER THAN 320122 AND NEEDLE PINCHES WHEN INSERTED INTO THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462812 PEN NDL 32G 4MM HP 100 BOX 1200 US PEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0203719 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1