BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PRI PLUM 15 MICRON CL 0.2M PE 272CM

    MDR report key: 8784760 · Received July 12, 2019

    Report

    Report Number
    9615050-2019-00248
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 17, 2019
    Report Date
    June 18, 2019
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED CRACKED MALE LUER WAS CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION. THE CUSTOMER PROVIDED SEVERAL PICTURES DOCUMENTING THE REPORTED SET WITH BROKEN MALE LUER TIP. THE TIP OF THE MALE LUER WAS STUCK INSIDE THE MATING DEVICE. WITHOUT THE RETURN OF THE PRODUCT A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE LOT REVIEW WAS PERFORMED WITH NO ISSUES NOTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PLUM SET WAS DAMAGED WITH TIP OF THE LUER DETACHED AND LEFT INSIDE THE INNER LUMEN OF PATIENT'S PICC FEMALE LUER CONNECTOR. THE PATIENT WAS BEING PREPPED FOR CHEMOTHERAPY (DOXORUBICIN 20MG + ETOPOSIDE 90MG + VINCRISTINE SULPHATE 0.8MG IN 1000 ML 0.9% NACL). THE NURSE FOUND IT DIFFICULT TO REMOVE THE PLUM SET MALE LUER ADAPTOR FROM PICC FEMALE LUER CONNECTOR. WHEN THE SET WAS REMOVED, THE MALE LUER TIP WAS DETACHED AND LEFT IN THE INNER LUMEN OF PICC FEMALE LUER. A SURGERY WAS ARRANGED FOR THE PATIENT TO REPLACE THE PICC. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORT OF AN ADVERSE EVENT OR DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579157 LS PRI PLUM 15 MICRON CL 0.2M PE 272CM SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 810635H

    Patients

    Seq Age Sex Outcome Treatment
    1 DOXORUBICIN| ETOPOSIDE| NACL| VINCRISTINE SULPHATE| DOXORUBICIN| ETOPOSIDE| NACL| VINCRISTINE SULPHATE