BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, RED CAP

    MDR report key: 19834487 · Received July 25, 2024

    Report

    Report Number
    9617594-2024-00947
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 15, 2024
    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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE IS UNKNOWN. 1 JAN 2024 HAS BEEN USED AS A PLACE HOLDER. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ON THE CH2000S-C COULD NOT BE CONFIRMED BY THE INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW (DHR) FOR LOT 13979429 WAS REVIEWED AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT. D9 - DEVICE AVAILABLE FOR EVALUATION: NO.

    Description of Event or Problem · 0

    AN EVENT INVOLVING A SPINNING SPIROS® CLOSED MALE LUER, RED CAP EXPERIENCED BREAKAGE AND LEAKAGE. IT WAS REPORTED THAT THE BREAKAGE CAUSED BLEEDING FOR THE PATIENT AND A CHEMO SPILL. SUBSEQUENT ITEMS FROM THE SAME LOT WERE NOTED TO HAVE THE SAME VULNERABILITY. OTHER LOT NUMBERS AT KOP (KING OF PRUSSIA) CAMPUS WERE ABLE TO BE USED WITHOUT ISSUE. AT THAT TIME IS SEEMS TO BE LIMITED TO ONE LOT. THEY ARE PERFORMING A SWEEP AND REMOVAL FOR EXISTING STOCK OF THAT LOT AND WILL PLAN TO RETURN/EXCHANGE. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN HARM OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922350 SPINNING SPIROS® CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13979429 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED CHEMO DRUG , MFR UNK