BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT

    MDR report key: 16564736 · Received March 17, 2023

    Report

    Report Number
    9615050-2023-00069
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 9, 2023
    Report Date
    March 7, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005230
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO (2) PHOTOS WERE RETURNED BY THE CUSTOMER SHOWING THE PRODUCT IN A SEALED BAG. NO LEAKAGE WAS VISIBLE. NO SAMPLES WERE RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW (DHR) FOR LOT: 5934289 WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH. THE REPORTER STATED THAT THE OPEN/CLOSE VALVE ON THE PHOTOPHOBIC SET LEAKED WHEN DRIPPING DRUGS. AS THE PHOTOPHOBIC SET IS USED TO DRIP CHEMOTHERAPY DRUGS, THERE IS A SAFETY CONCERN. MEDICAL SUPPLIES THAT HAVE USED CHEMOTHERAPY DRUGS SHOULD BE CAREFULLY CHECKED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824917 PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 1425628 5934289 10887787005230

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK CHEMOTHERAPY DRUG, UNK MFR