BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 11189566 · Received January 18, 2021

    Report

    Report Number
    9617594-2021-00007
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Date of Event
    December 22, 2020
    Report Date
    December 22, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026615
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TWENTY THREE NEW LIST# CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP. LOT# 4981626 THREE AND NEW C-CLIPS (TWO OF LOT 4711312 AND ONE OF LOT 5008641) WERE RECEIVED FOR EVALUATION. THERE WERE NO VISUAL ANOMALIES OR DAMAGE NOTED WITH ANY OF THE RETURNED ASSEMBLIES. THE TWENTY THREE NEW CH2000S-C SPINNING SPIROS ASSEMBLIES WERE EVALUATED FOR CONNECTION AND DISCONNECT TORQUE. EACH MET PRODUCT PERFORMANCE EXPECTATIONS OUTLINED IN THE PRODUCT PERFORMANCE SPECIFICATION. THE THREE C-CLIPS WERE CLIPPED TOGETHER AND MEASURED. EACH WERE SECURELY ENGAGED AND EACH MET DESIGN EXPECTATIONS. NO MALE LUER MATING DEVICES WERE RETURNED TO EVALUATE WITH THE NEW CH2000S-C SPINNING SPIROS AND C-CLIP ASSEMBLIES. EACH RETURNED C-CLIP WAS MEASURED FOR THICKNESS WHICH IS THE DIMENSION THAT WOULD SUPPORT SPIN COLLAR BACK OFF OF AN ALARIS MALE SPIN LUER. ALL 3 C-CLIPSS PASSED THE THICKNESS TEST. THE COMPLAINT WAS UNABLE TO BE REPLICATED OR CONFIRMED. A DEVICE HISTORY REVIEW FOR LOT# 4981626 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. CONCOMITANT MEDICAL PRODUCTS ARE AS FOLLOWS: 5" (13 CM) APPX 1.8 ML, BAG SPIKE ADAPTER W/CHEMOLOCK¿ W/RED CAP, VENTED CAP, LIST# CL3534, MFR ICU MEDICAL. TUBING SET, (LIST# AND MFR UNK). -UNSPECIFIED CHEMO DRUG (MFR UNK).

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP. IT WAS REPORTED THAT THE NURSE PREPARED FOR ADMINISTRATION WITH BD TUBING AND THE SPIROS. UPON CIRCLE PRIMING THE SET, THE DISTAL END OF THE TUBING FELL OFF OF THE SPIROS AND THE LINE STARTED DRIPPING AN UNSPECIFIED CHEMOTHERAPY DRUG. THE MEDICATION WAS THEN REMADE AND NEW TUBING WAS USED. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82791 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4981626 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1