BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31G 5 MM 3/16" MNI

    MDR report key: 14436581 · Received May 18, 2022

    Report

    Report Number
    MW5109779
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Report Date
    May 13, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INDICATION: AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE. PATIENT REPORTED THAT THE NEEDLE DOESN'T WANT TO COME OFF THE CARTRIDGE AND SHE IS NOT SURE SHE IS GETTING AN ADEQUATE DOSE. SHE HAS BEEN USING THE CURRENT PEN FOR ABOUT 3 WEEKS AND SHE DID MENTION SHE DROPPED IT ABOUT A WEEK AGO, BUT SHE STATED SHE WAS HAVING TROUBLE BEFORE DROPPING IT. THE NEEDLES MUST UNSCREW BY HAND AND AT THIS POINT THERE SHOULD BE LESS MEDICATION LEFT IN THE PEN, PER PATIENT. TYMLOS LOT RU01101, EXPIRATION DATE: 12/31/2024, NEEDLES LOT 1096044, EXP 4/30/2026. PROVIDED PATIENT WITH MANUFACTURER PHONE NUMBER TO REACH OUT FOR REPLACEMENT AND TRANSFERRED TO SET UP DELIVERY OF NEW PEN AND PEN NEEDLES. NO ADVERSE EVENTS REPORTED DUE TO MALFUNCTION. NO MISSED DOSES REPORTED. UNKNOWN IF PATIENT STILL HAS DEFECTIVE DEVICE ON HAND. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032392 PEN NEEDLE 31G 5 MM 3/16" MNI NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 1096044

    Patients

    Seq Age Sex Outcome Treatment
    1 Female TYMLOS