BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 12692099 · Received October 25, 2021

    Report

    Report Number
    3006425876-2021-00998
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 26, 2021
    Report Date
    October 9, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). NEW INFORMATION RECEIVED INDICATES THAT THIS WAS NOT A REPORTABLE EVENT; THUS, THE INITIAL MDR SUBMITTED ON 10/25/2021 SHOULD BE RETRACTED.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DILATOR TIP WAS FOUND DAMAGED DURING USE ON PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588480 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F20H2519

    Patients

    Seq Age Sex Outcome Treatment
    1