BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 16 GA X 8" (20 CM)

    MDR report key: 15714872 · Received November 2, 2022

    Report

    Report Number
    3006425876-2022-00925
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Date of Event
    September 8, 2022
    Report Date
    October 10, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 02-NOV-2022 SHOULD BE RETRACTED.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED IN (B)(6) 2022, THE SYRINGE/NEEDLE CONNECTION WAS FOUND NOT SECURED DURING USE ON THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. THE CURRENT PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911077 ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F21H1429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.| N/A.