BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 26X3/8 IB

    MDR report key: 18621856 · Received February 1, 2024

    Report

    Report Number
    1911916-2024-00049
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 19, 2024
    Report Date
    January 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051107
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION FOR DEVICE EVALUATION. AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Description of Event or Problem · 0

    NEEDLE SNAPPED OFF SYRINGE WHEN TRYING TO FILL CARTRIDGE DISTRIBUTOR COMPLAINT REPORT - INTERNATIONAL DISTRIBUTOR INFORMATION DISTRIBUTOR NAME: AUSTRALASIAN MEDICAL & SCIENTIFIC LTD TANDEM DISTRIBUTOR ACCOUNT NUMBER: (B)(4). DISTRIBUTOR INCIDENT REFERENCE NUMBER: (B)(4). COUNTRY OF EVENT: AUSTRALIA DATE DISTRIBUTOR NOTIFIED: 20 JAN 2024 INCIDENT INFORMATION EVENT DATE: 19 JAN 2024 PRODUCT CATEGORY: NEEDLE ISSUE EVENT DETAILS (ATTACH ADDITIONAL PAGES IF NEEDED AND DO NOT INCLUDE THE PERSONAL DATA OF ANY INDIVIDUAL): 1) CALLER REPORTED NEEDLE SNAPPED OFF SYRINGE WHEN TRYING TO FILL CARTRIDGE 2) DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO3) WITH HOW MANY SYRINGES/NEEDLES DID THE CALLER EXPERIENCE THE ISSUE? ¿ ONE 5) WAS THE SYRINGE/NEEDLE REUSED? - NO 6) PRODUCT WITH ISSUE - BD 26 G, 3/8" NEEDLE, PN 305110 7) IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ NO 8) PRODUCT LOT # - UNAVAILABLE 9) DID ISSUE CAUSE ANY INJURY? - NO 11) WAS CALLER ABLE TO FILL A CARTRIDGE WITH INSULIN? ¿ NO RESOLUTION ¿ REPLACED NEEDLE AND WAS ABLE TO FILL NEW ONE SEE ATTACHED FOR THE REST

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419786 NEEDLE 26X3/8 IB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON UNKNOWN 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown