BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13CM(5") APPX 0.37ML,SMALLBORE EXT SET W/PRE-PIERCED T-CONNECTOR,CLAMP,LUER SLIP

    MDR report key: 18114956 · Received November 10, 2023

    Report

    Report Number
    9617594-2023-00969
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    July 8, 2023
    Report Date
    November 10, 2023
    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
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF SEPARATION ON ITEM 126509260 NOT BE CONFIRMED BY INVESTIGATION. SINCE NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW (DHR) REVIEWED COULDN'T BE PERFORMED DUE TO LOT NUMBER FOR THIS COMPLAINT WAS UNKNOWN. USER FACILITY MEDWATCH# 1600820000-2023-8019.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A T-CONNECTOR TUBING, WHERE IT WAS REPORTED UPON POSITIONING AN INFANT FOR A CHEST X-RAY, THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) T-CONNECTOR TUBING WAS NOTED TO HAVE SNAPPED AT THE CONNECTION OF CLEAR TUBING TO GREEN CONNECTOR OF T-CONNECTOR. THE REPORTER STATED IT BROKE OFF WHERE #3 CONNECTS TO THE GREEN PIECE. THERE WERE NO ISSUES NOTED DURING INITIAL SET-UP/PRIMING OF THE T-CONNECTOR TUBING. THE ORIGINAL INTENDED PROCEDURE WAS IV FLUID ADMINISTRATION VIA PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE T-CONNECTOR WAS ATTACHED DIRECTLY TO A 1.2 FR L-CATH PICC LINE AND THE IV FLUID TUBING WAS THE STANDARD ALARIS PUMP TUBING. THERE WERE NO OBSERVED COMPONENT DAMAGES, ANOMALIES WITH THE OR THE MATING / ACCESS DEVICES. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125522 13CM(5") APPX 0.37ML,SMALLBORE EXT SET W/PRE-PIERCED T-CONNECTOR,CLAMP,LUER SLIP STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA Female 1.2 FR L-CATH PICC LINE, UNK MFR| STANDARD PUMP TUBING, ALARIS