BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 20208876 · Received September 12, 2024

    Report

    Report Number
    3024508819-2024-00323
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Report Date
    November 20, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED THAT THE NEEDLES BEND DURING INJECTION. CONSUMER ALSO REPORTED THAT THE NEEDLE BROKE OFF IN HIS INJECTION SITE. HE WAS ABLE TO REMOVE THE NEEDLE WITH HIS FINGERS WITHOUT INJURY OR DISCOMFORT. CONSUMER STATED THAT HE RE-USES THE NEEDLE BUT THE ISSUES OCCURRED WITH NEW NEEDLES. LOT #: 7053554 CATALOG #: 328466 DATE OF EVENT: UNKNOWN SAMPLES AVAILABLE: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111613 SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328466 UNKNOWN 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male