BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 10300978 · Received July 21, 2020

    Report

    Report Number
    9617594-2020-00254
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 25, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619023386
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION, HOWEVER, A PHOTOGRAPH WAS RETURNED SHOWING A 20130-01 SPINNING SPIROS CONNECTED TO A LUER LOCK SYRINGE AND VISIBLE LEAKAGE INTERNAL TO THE 20130-01 SPINNING SPIROS. THE DEVICE HISTORY REVIEW (DHR) WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THOUGH LEAKAGE CAN BE CONFIRMED, A PROBABLE CAUSE CANNOT BE IDENTIFIED WITHOUT THE RETURN OF THE AFFECTED SAMPLE.

    Description of Event or Problem · 1

    THE EVENT OCCURRED BETWEEN (B)(6) 2020 AND INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE THE SPIROS SANK AND DID NOT REMAIN STILL OR TILTED DURING AN INFUSION OF DOXORUBICIN USING A 12 CC SYRINGE RESULTING IN A LEAK. THERE WAS NO APPARENT PHYSICAL DEFECT OBSERVED ON THE SPIROS. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS ONE OF TWO INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769494 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4749754 00840619023386

    Patients

    Seq Age Sex Outcome Treatment
    1