BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM

    MDR report key: 10267949 · Received July 13, 2020

    Report

    Report Number
    9680794-2020-00310
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 1, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). INFORMATION FROM THIS COMPLAINT WAS CAPTURED UNDER MDR#9680794-2020-00311, THUS THIS MDR SHOULD BE VOIDED AS IT IS DUPLICATE INFORMATION.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). TWO MDRS SUBMITTED: SPRING WIRE GUIDE KINKED. 9680794-2020-00311 - SPRING WIRE GUIDE UNRAVELED. LOT# UNKNOWN. POTENTIAL LOT# 13F20B0001.

    Description of Event or Problem · 1

    DURING CVC INSERTION THE GUIDE WIRE KINKED AND BEGAN TO UNRAVEL. THE REPORTED DEFECT WAS DETECTED DURING USE. THE PATIENT CONDITION IS REPORTED AS "FINE". THERE WAS NO PATIENT HARM/INJURY/CONSEQUENCE. THERAPY WAS NOT DELAYED/INTERRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728716 ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1