BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, RED CAP

    MDR report key: 8894193 · Received August 14, 2019

    Report

    Report Number
    9617594-2019-00269
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 30, 2019
    Report Date
    August 1, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - ONE USED LIST# CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP. LOT # 4040735 AND ONE USED 35 ML SYRINGE, MANUFACTURER MONOJECT WERE RECEIVED FOR EVALUATION ON 8/9/2019. THE SPINNING SPIROS WAS PRESSURE LEAK TESTED AS PER THE PRODUCT PERFORMANCE SPECIFICATION AND NO LEAKAGE WAS OBSERVED AT ANY LOCATION WITHIN THE SPINNING SPIROS ASSEMBLY. THE SPIN FEATURE WAS SPINNING FREELY AND THE MATING DEVICE MALE AND FEMALE LUERS WERE ISO COMPATIBLE. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. A DEVICE HISTORY REVIEW (DHR) FOR LOT# 4040735 AND RELEVANT COMMODITIES WERE REVIEWED. NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. D11 - UPDATED INFORMATION - 35ML SYRINGE, MFR MONOJECT ADDITIONAL INFORMATION CAN BE FOUND IN SECTION G1.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS BEING THAT WHEN USED WITH AN UNSPECIFIED SYRINGE, A LEAK OF FLUOROURACIL WAS NOTED AROUND THE TIP OF THE SYRINGE AND THE CHEMO SPILLED ON THE PATIENT. THE SYRINGE WAS REMADE. THERE WAS NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688605 SPINNING SPIROS® CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4040735 00840619026615

    Patients

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