BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS

    MDR report key: 8854685 · Received August 2, 2019

    Report

    Report Number
    9617594-2019-00256
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 15, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619042769
    PMA / PMN Number
    K070532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ONE (1) USED NEEDLE UNKNOWN MANUFACTURER, ONE (1) USED LIST# CH2000SC-10, SPIROS, CLOSED MALE CONNECTOR W/RED CAP, (B)(4) UNITS. LOT# 3987645, ONE(1) SYRINGE USED, MANUFACTURER BD WERE RECEIVED FOR EVALUATION. THE COMPLAINT OF LEAKING FROM THE SIDE OF THE SPIROS WAS CONFIRMED. THE PROBABLE CAUSE OF THE LEAKAGE IS AN INCOMPLETE LUER CONNECTION DURING USE CAUSED BY THE SMALL LUER THREADS GETTING CAUGHT BETWEEN THE PUSH ARMS OF THE SPIROS POPPET RESULTING IN FLOODING OF THE INTERNAL PORTION OF THE SPIROS WHICH LEAKS OUT THE STRAP SLOTS. A DEVICE HISTORY REVIEW FOR LOT# 3987645 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION IN H3.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, BUT IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPIROS THAT HAD A CRACK NEAR THE TOP ALLOWING FOR VIDAZA TO LEAK OUT THE SIDES. THE EVENT OCCURRED WHILE THE PATIENT WAS RECEIVING AN INJECTION. IT WAS REPORTED THAT ALCOHOL SWABS WERE USED TO DISINFECT THE AREA BEFORE GIVING THE INJECTION. THE MEDICATION WAS DRIPPING OUT OF AN UNSPECIFIED BECTON DICKINSON (BD) SYRINGE ONTO THE CHAIR AND THE PATIENT. THERE WERE NO ADVERSE EVENTS REPORTED AND STANDARD PROCEDURES WERE FOLLOWED AFTER THE INCIDENT. THE DEVICE WAS NOT REPLACED BECAUSE ONLY 2ML WAS NEEDED FOR THE INJECTION AND WAS STILL ABLE TO BE PROVIDED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651809 SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3987645 00840619042769

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSP BD SYRINGE.| VIDAZA, MFR UNK.| UNSP BD SYRINGE| VIDAZA, MFR UNK