BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5" (13 CM) BAG SPIKE ADAPTER W/SPIROS® W/RED CAP, VENTED CAP

    MDR report key: 9532032 · Received December 30, 2019

    Report

    Report Number
    9617594-2019-00432
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    November 11, 2019
    Report Date
    December 6, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00840619024116
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: RECEIVED ONE USED LIST# CH3034, 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP. THE COMPLAINT OF SEPARATION COULD BE CONFIRMED ON THE USED CH3034. AS RECEIVED THE SPINNING SPIROS WAS ATTACHED AND THE BOND STRENGTH WAS TESTED PER PRODUCT SPECIFICATION. THE SPINNING SPIROS SEPARATED FROM THE SMALL BORE LUER. BOTH THE SPIROS AND THE SMALL BORE MALE LUER WERE VISUALLY INSPECTED AND IT WAS OBSERVED TO HAVE INSUFFICIENT SOLVENT PRESENT. THE PROBABLE CAUSE OF THE INSUFFICIENT SOLVENT PRESENT ON THE BOND OF THE SPIROS TO THE SMALL BORE MALE LUER IS DUE TO A MISS ASSEMBLY DURING THE MANUAL ASSEMBLY AT THE MANUFACTURING LOCATION IN ENSENADA. A DEVICE HISTORY REVIEW (DHR) FOR LOT# 4080711 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCE'S WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, HOWEVER, INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS® W/RED CAP, VENTED CAP THAT THE CUSTOMER REPORTED DURING INFUSION THE TUBE CONNECTION BROKE AT THE JOINT BETWEEN THE SPIROS AND TUBING WHICH RESULTED IN AN UNSPECIFIED CHEMO LEAK. NO MORE INFORMATION WAS PROVIDED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF ADVERSE EVENT OR A DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324786 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS® W/RED CAP, VENTED CAP CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CH3034 4080711 00840619024116

    Patients

    Seq Age Sex Outcome Treatment
    1