BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP

    MDR report key: 15163526 · Received August 4, 2022

    Report

    Report Number
    9617594-2022-00224
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 15, 2022
    Report Date
    July 22, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619058043
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. HOWEVER; IT HAS NOT YET BEEN RECEIVED. WITHOUT THE RETURN OF THE SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF A PARTICULATE INSIDE THE FLUID PATH CAN BE CONFIRMED ON THE RETURNED ONE (1) OPEN/UNUSED. LIST #011-H3393, 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP; LOT #5872617. AS RECEIVED THERE WAS A WHITE TRANSLUCENT PARTICULATE INSIDE THE TUBING. THE PARTICULATE WAS 5 IN^2 IN SIZE. THE LARGE SIZE OF THE PARTICULATE FAR EXCEEDS THE PRODUCT SPECIFICATION. THE PARTICULATE WAS SUBMITTED TO AN FT-IR TO DETERMINE THE ORIGIN OF THE PARTICULATE. THE PARTICULATE WAS DETERMINED TO HAVE A STRONG CORRELATION WITH PVC WHICH IS THE SAME MATERIAL AS THE TUBING. THE PROBABLE CAUSE OF THE PARTICULATE INSIDE THE TUBING IS TUBING DEBRIS FROM THE MANUFACTURING SITE. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION: D9 - DATE RETURNED TO MFG: 8/8/2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NURSE FROM THE OUTPATIENT DEPARTMENT, UPON OPENING THE STERILE PACKAGING, NOTICED THE PRESENCE OF AN IMPURITY IN THE CONNECTION SITE OF THE INFUSION SET. THE DEVICE HAS BEEN QUARANTINED AND HAS NOT BEEN USED. THERE IS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENTS/HUMAN HARM. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681899 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP STOPCOCK, I.V. SET FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5872617 00840619058043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown