BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36 CM (14¿) APROX 4,6 ML, SET LINEAL PUR, C/PUNZÓN C/VÁLVULA, MICROCLAVE®, FILTR

    MDR report key: 9503969 · Received December 20, 2019

    Report

    Report Number
    9617594-2019-00429
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    November 27, 2019
    Report Date
    December 16, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION, HOWEVER, A SERIES OF PHOTOGRAPHS WERE RECEIVED AND EVALUATED. THE PHOTOS SHOW ONE USED 034-H2782 SET. THE TUBING APPEARS TO BE SEPARATED FROM THE DISTAL END OF THE Y-CLAVE. INSUFFICIENT SOLVENT IS VISIBLE ON THE Y-CLAVE AND THE TUBING. THE DEVICE HISTORY REVIEW (DHR) FOR POSSIBLE LOT NUMBERS 4094384 AND 4040743 WERE REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT CAN BE CONFIRMED BASED ON THE PHOTO PROVIDED. THE PROBABLE CAUSE IS DUE TO AN ERROR IN THE MANUAL BONDING PROCESS DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT RETURN FOR EVALUATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED TWO POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 4094384 (EXPIRY DATE 05/01/2024 , MFR DATE 05/01/2019) AND 4040743 (EXPIRY DATE 04/01/2024, MFR DATE 4/01/2019).

    Description of Event or Problem · 1

    THE EVENT INVOLVED AN EXTENSION SET THAT DURING THE MIDDLE OF AN INFUSION OF PACLITAXEL A LEAK WAS NOTED. THE EXTENSION SET WAS REPLACED, AND THE TREATMENT WAS COMPLETED. THERE WAS NO ADVERSE EVENT, NO HARM REPORTED, NO DELAY IN CRITICAL THERAPY AND NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295307 36 CM (14¿) APROX 4,6 ML, SET LINEAL PUR, C/PUNZÓN C/VÁLVULA, MICROCLAVE®, FILTR STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 PACLITAXEL, MFR UNK