BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEC 20DP, TEXIUM & HANGER V/NV

    MDR report key: 11319430 · Received February 11, 2021

    Report

    Report Number
    9616066-2021-50216
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 13, 2021
    Report Date
    January 23, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403225626
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: TWO SAMPLES WERE RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF FOREIGN MATTER WAS VERIFIED BY VISUAL INSPECTION. INSPECTION OF THE INFUSION SETS SHOWED THAT THERE WAS A WHITE SUBSTANCE ON THE MALE LUER CONNECTIONS (P/N 1001-143-022) AT THE DISTAL END OF BOTH OF THE INFUSION SETS. A DEVICE HISTORY RECORD REVIEW FOR MODEL 40000-07T LOT NUMBER 19125907 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 17,283 UNITS IN 1 LOT NUMBER WAS BUILT ON 10DEC2019. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ROOT CAUSE FOR THIS ISSUE IS THE EXCESS AMOUNT OF SOLVENT USED IN BONDING THE TUBING TO THE LUER CONNECTION. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEC 20DP, TEXIUM & HANGER V/NV HAD WHITE RESIDUE ON THE MALE LUER CONNECTOR. THIS WAS FOUND ON 2 SETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHITE RESIDUE PRESENT AT MALE LEUR CONNECTOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215559 SEC 20DP, TEXIUM & HANGER V/NV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 40000-07T 20095691 50885403225626

    Patients

    Seq Age Sex Outcome Treatment
    1