BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 11611860 · Received April 3, 2021

    Report

    Report Number
    3012307300-2021-02806
    Event Type
    Malfunction
    Date Received
    April 3, 2021
    Date of Event
    February 26, 2021
    Report Date
    August 24, 2021
    Product Code
    LGZ
    UDI-DI
    30695085407007
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITH MEDICAL FLUID WARMING/LEVEL 1 HOTLINE DISPOSABLES. TWO PICTURES WERE PROVIDED, AS PRESUMED A POSSIBLE CRACKING ON CONNECTOR. AFTER VISUAL INSPECTION WAS PERFORMED TO SAMPLE UNIT, SEE PICTURES ABOVE, NO MARKS OR STAINS WERE OBSERVED ON TUBE SURFACE, NEITHER ON REFLUX CONNECTOR OR SWIVEL CONNECTOR, IN THE LUER LOCK ADAPTER FEMALE P/N 00-208 IS VISIBLE A CRACKING, THEREFORE, FAILURE MODE REPORTED CAN BE OBSERVED. RESULTS FOR FUNCTIONAL TEST IN SAMPLE PROVIDED: BASED ON MANUFACTURING PROCEDURE MP L-70 REV.117 AND FAILURE MODE REPORTED, WE PERFORMED A LEAKAGE TEST ON SAMPLE PROVIDED, IN ORDER TO VERIFY IF LEAKAGE CAN BE CONFIRMED OR NOT CAUSED BY CRACKING ON LUER CONNECTOR, AFTER TEST WAS PERFORMED TO THE PIECE, SAMPLES DOESN?T PASS SUCCESSFULLY LEAKAGE TEST. RESULTS FOR FUNCTIONAL TEST IN SAMPLE PROVIDED: BASED ON MANUFACTURING PROCEDURE MP L-70 REV.117 AND FAILURE MODE REPORTED, WE PERFORMED A LEAKAGE TEST ON SAMPLE PROVIDED, IN ORDER TO VERIFY IF LEAKAGE CAN BE CONFIRMED OR NOT CAUSED BY CRACKING ON LUER CONNECTOR, AFTER TEST WAS PERFORMED TO THE PIECE, SAMPLES DOESN?T PASS SUCCESSFULLY LEAKAGE TEST. BASED ON THE SAMPLE PROVIDED, ANALYSIS CONDUCTED ON PHYSICALLY EVALUATION, TREND ANALYSIS FOR THIS FAILURE MODE IN COMPLAINTS, AND RMP 1034 REV. 100 ROOT CAUSE CAN BE DETERMINED AS SUPPLIER ITEM FAULT. CONTAINMENT AWARENESS NOTIFICATION FOR FAILURE MODE REPORTED TO PRODUCTION PERSONNEL WAS ISSUED BY THE QUALITY ENGINEER. ADDITIONALLY, ALL MITIGATION'S ON PLACED WERE VERIFIED AND IT WAS CONFIRMED EXECUTION ACCORDINGLY

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARY IN H 10.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMMEDIATELY AFTER STARTING TO USE THE PRODUCT, THE CUSTOMER FOUND A CRACKING THE CONNECTOR. SO HE STOPPED USING THE PRODUCT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509092 LEVEL 1 WARMER, THERMAL, INFUSION FLUID LGZ L-70 30695085407007

    Patients

    Seq Age Sex Outcome Treatment
    1