BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP

    MDR report key: 11723468 · Received April 26, 2021

    Report

    Report Number
    9617594-2021-00135
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    February 1, 2021
    Report Date
    March 30, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709079243
    PMA / PMN Number
    K081361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTOGRAPH OF THE PRODUCT PACKAGING WAS PROVIDED AND EVALUATED. THE SPIROS WAS NOT VISIBLE IN THE IMAGE. NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION. THE DHR FOR LOT NUMBER 5030925 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT CANNOT BE CONFIRMED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED ONCOLOGY KIT W/SPINNING SPIROS®, C-CLIP, RED CAP WHICH LEAKED UNSPECIFIED CHEMOTHERAPY ON PATIENT OR HEALTHCARE PROVIDER. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE AND ALL PARTS WERE IN PLACE APPROPRIATELY. NO HOLE, CUT, TEARS OR ANY DEFECT NOTED; IT WAS ALL OVER THE CLOSED BAG SO THE USER COULD NOT FULLY MANIPULATE. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WAS NO BLOOD LOSS OR BLEED BACK. THE DRUG WAS REPLACED AND NO FURTHER ISSUES WERE REPORTED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO ADVERSE OUTCOME AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623491 ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5030925 00887709079243

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED CHEMOTHERAPY, MFR UNK