BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN BIFURCATED EXTENSION SET WITH SWAN-LOCK'S & MALE LUERLOCK

    MDR report key: 19816474 · Received July 24, 2024

    Report

    Report Number
    19816474
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 23, 2024
    Report Date
    June 24, 2024
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BIFLOW CONNECTED AND INFUSING D10 (DEXTROSE 10%) 1/4NS (NORMAL SALINE) WITH 1 UNIT OF HEPARIN PER ML THROUGH BROVIAC. BIFLOW HAD TO BE DISCONNECTED AND WHEN RECONNECTED THE LUER LOCK PIECE OF THE BIFLOW CRUMBLED. PATIENT'S MOTHER WAS AT BEDSIDE AND STATED THAT THIS HAS HAPPENED 2-3 OTHER TIMES (THAT SHE IS AWARE OF). BIFLOW WAS REPLACED - NO HARM TO PATIENT. MANUFACTURER RESPONSE FOR BIFURCATED EXTENSION SET WITH SWAN-LOCK & MALE LUERLOCK, (CODAN) (PER SITE REPORTER). THE MANUFACTURER STATES THEY FEEL IT WAS RELATED TO CHG (CHLORHEXIDINE) USE. HOWEVER, THIS IS NOT AN AREA WE WOULD TYPICALLY PLACE CHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366467 CODAN BIFURCATED EXTENSION SET WITH SWAN-LOCK'S & MALE LUERLOCK SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION BC 246 78158

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female