BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 20CM

    MDR report key: 644664 · Received September 26, 2005

    Report

    Report Number
    1036844-2005-00074
    Event Type
    Malfunction
    Date Received
    September 26, 2005
    Date of Event
    August 26, 2005
    Report Date
    September 6, 2005
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED EXT LINE WAS SEPARATED FROM JUNCTURE HUB. JUNCTURE HUB WAS CUT OPEN AND EVALUATED. EXT LINE TUBING WAS SUFFICIENTLY INSERTED INTO MOLD CAVITY & JUNCTURE HUB WAS MOLDED PER SPECIFICATION. EXT LINE IS NARROWED AND EXTENDED APPROX. 1.5CM. EXCESSIVE FORCE WAS MOST LIKELY APPLIED TO EXT LINE CAUSING THE SEPARATION. WITHOUT LOT #, DHR COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED ON AUGUST 25, 2005 VIA SUBCLAVIAN VEIN. IN 2005, DOCTOR NOTICED EXTENSION LINE WAS SEPARATED FROM JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 7 FR X 20CM ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention