BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 18952364 · Received March 21, 2024

    Report

    Report Number
    1920898-2024-05064
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    February 22, 2024
    Report Date
    June 12, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    UDI-DI
    00382908411035
    PMA / PMN Number
    K190054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    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. THIS IS THE 1ST. COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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 NEEDLE BREAK, STATED THAT ON 2-22-24 THE NEEDLE BROKE OFF IN THE INJECTION SITE. CONSUMER SAID THAT HE WENT TO THE ER AND HAD X-RAYS DONE. HE SAID A TOTAL OF 8 NEEDLES WERE SEEN ON THE X-RAYS. CONSUMER SAID HE IS GOING TO CONTACT HIS ATTORNEY. LOT #: 3233260. CATALOG #: 328411. DATE OF EVENT: 2-22-24. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524358 SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 328411 3233260 00382908411035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown