BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 15445301 · Received September 19, 2022

    Report

    Report Number
    3012307300-2022-19604
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 19, 2019
    Report Date
    September 19, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JKA
    UDI-DI
    20351688062953
    PMA / PMN Number
    K923090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTION WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. THE RETURNED SAMPLES CONSIST OF TWO (2) SAF-T-WING PRODUCT, THE RETURNED SAMPLES WERE RECEIVED IN NEW CONDITION WITH ITS ORIGINAL CLOSED PACKAGE. VISUAL INSPECTION SHOWS THE SAMPLES WERE VISUALLY INSPECTED, AT 12" TO 16" AND NORMAL CONDITIONS OF ILLUMINATION. RESULTS SHOWS ONE SAMPLE OBSERVE THE LUER OF THE SAF-T HOLDER PRODUCT BROKEN, THE OTHER SAMPLE NO DEFECT FOUND. PER PREVIEW COMPLAINTS A REVIEW OF MANUFACTURING PROCESS WAS CONDUCTED BY QUALITY ENGINEER, IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT AS DESCRIBED IN DESCRIPTION OF NON-CONFORMANCE" SECTION. IN ORDER TO REPRODUCE THE FAILURE MODE REPORTED BY CUSTOMER, WE MAKE THE FOLLOWING TEST USING PRE-STERILE AND POST-STERILE MATERIAL. PRODUCTION PERFORMS A 100% IN PROCESS INSPECTION, IN ORDER TO VERIFY FOR DAMAGE OR CRACKED SECTIONS IN THE MALE LUER. IN THE PACKAGING AREA, PRODUCTION PERFORMS A 100% IN PROCESS INSPECTION, IN ORDER TO VERIFY THAT THE PRODUCTS ARE FREE OF DAMAGE IN THE MALE LUER. THE MOST PROBABLE ROOT CAUSES ARE, THE "CRACK LUER" FAILURE IS ATTRIBUTABLE TO AN EXPOSURE OF THE PRODUCT TO ALCOHOL IN COMBINATION WITH EXCESSIVE FORCE. THE LUER COME WEAK FROM SUPPLIER. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN CONJUNCTION WITH THE PVK SETTING WITH BLUE NEXIVA, BLOOD CULTURE IS TAKEN FROM THE PVK BY MEANS OF SAFTHOLDER WHICH IS CONNECTED TO THE PVK AND THE BLOOD SAMPLES ARE TAKEN. WHEN THE SAFTHOLDER IS THEN DISCONNECTED FROM THE PVK, IT HAS BROKEN AND A PIECE OF PLASTIC REMAINS IN THE PVK MOUTH. UNABLE TO REMOVE PLASTIC AND HOSE TO PVK MUST BE REPLACED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521811 JELCO TUBES, VIALS, SYSTEMS, SERUM SEPARATORS JKA SMITHS MEDICAL ASD, INC. 96000 3693972 20351688062953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown