BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, RED CAP

    MDR report key: 8508750 · Received April 12, 2019

    Report

    Report Number
    9617594-2019-00111
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 17, 2019
    Report Date
    March 18, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE (1) USED, LIST # CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP; LOT # UNKNOWN, ONE (1) USED, EMPTY 30ML SYRINGE BY BD, ONE (1) USED, LIST # CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP; LOT # UNKNOWN, THREE (3) NEW, LIST # CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP; LOT #S 3963908, 3895030, & 3895032, AND ONE (1) NEW, REF. 10013072, BD ALARIS PUMP INFUSION SET. THE REPORTED PRODUCT PROBLEM FOR THE SPIROS THAT IT DISCONNECTS AND THEN LEAKS COULD NOT BE REPLICATED. THE SPIROS MET THE VISUAL INSPECTION, THE DIMENSIONAL ISO STANDARD LUER TAPER INSPECTION AND THE FUNCTIONAL TORQUE INSPECTION PER THE PRODUCT PERFORMANCE SPECIFICATION WITHOUT ANY ISSUES. THE TESTING DID NOT SHOW THAT THE SPIROS DISCONNECTS AND LEAKS. DHR LOT#S 3963908, 3895030, & 3895032 AND RELEVANT COMPONENTS REVIEW WERE CONDUCTED AND NO NON RELEVANT NON CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. TESTING AND INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPIROS THAT DISCONNECTED FROM THE IV TUBING DURING INFUSION THAT SPILLED AN UNSPECIFIED CHEMOTHERAPY DRUG. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY, HOWEVER NO REPORT OF HUMAN HARM, NO ADVERSE EVENT, NO BLOOD LOSS, NO MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301669 SPINNING SPIROS® CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED CHEMOTHERAPY.| UNSPECIFIED CHEMOTHERAPY