BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP

    MDR report key: 17452987 · Received August 3, 2023

    Report

    Report Number
    9617594-2023-00485
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    January 1, 2020
    Report Date
    July 18, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00840619027568
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE PROVIDED FOR INVESTIGATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON AUGUST 07, 2023: THE INCIDENT WAS OBSERVED DURING THE PREPARATION OF CYCLOPHOSPHAMIDE FOR THE PUI (HOSPITAL PHARMACY) BEFORE DISPENSING TO CARE SERVICES. NO ADVERSE EVENTS, NO HUMAN HARM, NO DELAY IN THERAPY, NO BLOOD LOSS AND NO PHYSICAL DEFECTS WERE OBSERVED BEFORE USE. NO LEAKAGE WAS NOTED. THE INCIDENT WAS OBSERVED AT THE END OF DRUG PREPARATION.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE (DURING THE FIRST SEMESTER OF 2020) IT AND INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP. THE CUSTOMER REPORTED THAT THE DEVICE HAD A DEFECTIVE SCREW THREAD THAT DID NOT LOCK, LEADING TO DISCONNECTION. THERE WAS NO REPORT OF HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281118 SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP SET, ADMINISTRATION, INTRAVASCULAR ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4352075 00840619027568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CYCLOPHOSPHAMIDE, MFR UNK