BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 11810500 · Received May 11, 2021

    Report

    Report Number
    9616656-2021-00510
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD ULTRA FINE¿ PEN NEEDLES 4MM X 32G WERE UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 AND BATCH NO. UNKNOWN. IT WAS REPORTED THAT NEEDLE BENDS AT PATIENT END DURING INJECTION AND NEEDLE CLOGS DURING INJECTION. LOT #: 7052840 (THE LOT NUMBER DOES NOT MATCH THE REPORTED MATERIAL NUMBER). DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE : UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD ULTRA FINE¿ PEN NEEDLES 4MM X 32G WERE UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 320122 AND BATCH NO. UNKNOWN IT WAS REPORTED THAT NEEDLE BENDS AT PATIENT .END DURING INJECTION AND NEEDLE CLOGS DURING INJECTION. LOT #: 7052840 (THE LOT NUMBER DOES NOT MATCH THE REPORTED MATERIAL NUMBER). DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706165 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 UNKNOWN 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1