BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC KIT: 3-LUMEN 7FR X 20CM

    MDR report key: 10507467 · Received September 9, 2020

    Report

    Report Number
    3006425876-2020-00794
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    August 27, 2020
    Report Date
    August 27, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). NEW INFORMATION RECEIVED INDICATES THAT THIS EVENT IS NON-REPORTABLE, THUS, THE INITIAL MDR SUBMITTED ON 09/09/2020 WAS SENT IN ERROR.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). POTENTIAL LOT# - 71F20C0736.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "PUNCTURE NEEDLE WAS LEAKING AT THE CONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973623 ARROW CVC KIT: 3-LUMEN 7FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC FOZ ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1