BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 11159458 · Received January 13, 2021

    Report

    Report Number
    9616656-2020-01360
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    February 23, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    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 THE BD ULTRA-FINE¿ PEN NEEDLE WOULD NOT PUSH OUT INSULIN DURING USE. THIS OCCURRED 1 TIME IN LOT 8338617, AND 2 TIMES IN AN UNSPECIFIED LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN INJECTING THEY WILL NOT PRESS OUT INSULIN WITH DIFFERENT BOXES. INFORMED NON PATIENT END PLACEMENTLOT #: 8338617 & 9072616 (MIGHT HAVE BEEN PRO) AND ONE UNKNOWN CATALOG#: 320144, DATE OF EVENT: UNKNOWN DIFFERENT DAYS".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8338617, MEDICAL DEVICE EXPIRATION DATE: 2023-11-30, DEVICE MANUFACTURE DATE: 2018-12-04; MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WOULD NOT PUSH OUT INSULIN DURING USE. THIS OCCURRED 1 TIME IN LOT 8338617, AND 2 TIMES IN AN UNSPECIFIED LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN INJECTING THEY WILL NOT PRESS OUT INSULIN WITH DIFFERENT BOXES. INFORMED NON PATIENT END PLACEMENT LOT #: 8338617 & 9072616 (MIGHT HAVE BEEN PRO) AND ONE UNKNOWN CATALOG#: 320144, DATE OF EVENT: UNKNOWN DIFFERENT DAYS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57648 BD ULTRA-FINE PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1