BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE

    MDR report key: 13159655 · Received January 4, 2022

    Report

    Report Number
    9616656-2021-01599
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 7, 2021
    Report Date
    January 20, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1138218. MEDICAL DEVICE EXPIRATION DATE: 05/31/2026. DEVICE MANUFACTURE DATE: 05/18/2021. MEDICAL DEVICE LOT #: 1132252. MEDICAL DEVICE EXPIRATION DATE: 05/31/2026. DEVICE MANUFACTURE DATE: 05/12/2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1138218. MEDICAL DEVICE EXPIRATION DATE: 05/31/2026. DEVICE MANUFACTURE DATE: 05/18/2021. MEDICAL DEVICE LOT #: 1132252. MEDICAL DEVICE EXPIRATION DATE: 05/31/2026. DEVICE MANUFACTURE DATE: 05/12/2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND THREE PHOTOS WERE RETURNED FROM AN UNKNOWN LOT. NO., CAT. NO. 320136. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND NO ISSUES WERE OBSERVED. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLE THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE CUSTOMER REPORTED THAT THE NEEDLE PE WAS BROKEN AND THUS IT COULD NOT BE INSERTED FOR INJECTION. THE LOT NUMBER IS EITHER 1138218 OR 1132252."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE CUSTOMER REPORTED THAT THE NEEDLE PE WAS BROKEN AND THUS IT COULD NOT BE INSERTED FOR INJECTION. THE LOT NUMBER IS EITHER 1138218 OR 1132252."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE CUSTOMER REPORTED THAT THE NEEDLE PE WAS BROKEN AND THUS IT COULD NOT BE INSERTED FOR INJECTION. THE LOT NUMBER IS EITHER 1138218 OR 1132252.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512810 BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown