BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

    MDR report key: 10900896 · Received November 25, 2020

    Report

    Report Number
    9616656-2020-01183
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 2, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320883, BATCH NO: 7151706. CONSUMER REPORTED PACKAGE DID NOT HAVE EXPIRATION DATE PRINTED ON IT. BOX WAS NOT OPENED. IT WAS DETERMINED BOX EXPIRED IN 2022 FROM THE LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320883, BATCH NO: 7151706. VERBATIM: CONSUMER REPORTED PACKAGE DID NOT HAVE EXPIRATION DATE PRINTED ON IT. BOX WAS NOT OPENED. IT WAS DETERMINED BOX EXPIRED IN 2022 FROM THE LOT NUMBER PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372145 PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8975 7151706 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1