BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER ADAPTER

    MDR report key: 14742432 · Received June 20, 2022

    Report

    Report Number
    9681835-2022-00011
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Report Date
    June 20, 2022
    Manufacturer
    TERUMO CORPORATION - KOFU
    Product Code
    JKA
    PMA / PMN Number
    K983490
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: REQUESTED, NOT PROVIDED, LOT NUMBER: REQUESTED, UNKNOWN, EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER, UDI - NOT REQUIRED FOR PRODUCT CODE, IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, INITIAL REPORTER NAME : MR./MS. (B)(6), OCCUPATION: OFFICE CLERK. (B)(4). NO SAMPLES WERE RETURNED FOR OUR INVESTIGATION. WHEN WE CLOSELY CHECKED THE RETENTION SAMPLES OF THE MOST RECENT LOT, NO DEFORMATION OR DEFECTIVE MOLDING CONDITION WERE OBSERVED IN EACH PART, INCLUDING PUSH BUTTONS AND CAPS OF BLOOD COLLECTION TUBE HOLDER. MOREOVER, NO DEFECTIVE SHAPES WERE OBSERVED IN THE HUB OF LUER ADAPTER S, WHICH IS THE CONNECTION PART WITH BLOOD COLLECTION TUBE HOLDER. DRAWING PERFORMANCE WAS CHECKED UTILIZING WATER AND OUR IN-HOUSE BLOOD COLLECTION TUBE, WHEREIN WATER WAS ABLE TO BE DRAWN AND NO BREAKAGE OR DISCONNECTION BETWEEN LUER ADAPTER S AND BLOOD COLLECTION TUBE HOLDER WAS OBSERVED. THE MANUFACTURE INSPECTION RECORDS OF THE REPORTED PRODUCT TYPE FOR TWO AND HALF PAST YEARS WERE TRACED BACK AND REVIEWED. AS A RESULT, NO DEFECTIVE CONDITION, WHICH MAY HAVE CAUSED PRODUCT BREAKAGE, WAS NOTED. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4). IS SUBMITTING THIS REPORT ON BEHALF OF KOFU FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A NEEDLE STICK. THE CONNECTION BETWEEN THE NEEDLE ATTACHMENT (WHITE PORTION) AND THE TRANSPARENT PART (HOLDER BODY) CAME OFF. SINCE THIS ISSUE OCCURRED DURING MANIPULATION, THE USER RECEIVED A NEEDLE STICK INJURY. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018516 LUER ADAPTER TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA TERUMO CORPORATION - KOFU N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown