BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN

    MDR report key: 16293466 · Received February 3, 2023

    Report

    Report Number
    9615050-2023-00025
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 10, 2023
    Report Date
    January 31, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787008804
    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

    A PHOTO WAS RETURNED BY THE CUSTOMER SHOWING THE CLAVE AT THE UPPER LID OF THE BURETTE. FLUID WAS OBSERVED AT THE CONNECTION OF THE SEMIRIGID ADAPTOR OF THE CLAVE TO THE UPPER LID OF THE BURETTE. NO SAMPLES WERE RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT OF LEAKS CAN BE CONFIRMED ON THE 142730490 PLUM 150 ML BURETTE SET BASED ON VISUAL REVIEW OF THE CUSTOMER-PROVIDED PHOTOGRAPH. THE PROBABLE CAUSE IS UNKNOWN. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE DETERMINED. THE DEVICE HISTORY RECORD (DHR) FOR LOT 6871731 WAS REVIEWED AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE CUSTOMER HAS DISCARDED IT. A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER AND EVALUATION OF THIS IS STILL PENDING. INITIAL REPORTER ADDITIONAL CONTACT: (B)(6).

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN. THE CUSTOMER REPORTED A FLUID LEAK OF 5-FU FROM THE CLAVE PORT OF 150 ML CYLINDER DURING INFUSION. THERE WAS NO OBVIOUS DEFECTS NOTED ON THE TUBING SET; NO HOLES, CUTS, TEARS OR ANY OTHER DEFECTS NOTED. THE TUBING WAS REPLACED AND THERAPY RESUMED. THE PRODUCTS WERE STORED IN THE AIR-CONDITIONED ROOM IN THE HOSPITAL. THERE WAS NO CASSETTE TEST FAILURE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770632 PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 1427329 6871731 10887787008804

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 5-FU, MFR UNKNOWN.