BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/18 IN

    MDR report key: 7487112 · Received May 4, 2018

    Report

    Report Number
    3004365956-2018-00147
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 19, 2018
    Report Date
    April 19, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). A MEDWATCH WAS RECEIVED FROM THE USER FACILITY (MEDWATCH # LISTED ON REPORT IS 310001-2018-0001). IT WAS DISCOVERED THAT THE COMPLAINT WAS ALREADY REPORTED TO THE FDA ON 03/28/2018 UNDER MDR# 3004365956-2018-00093; THUS THIS MDR IS A DUPLICATE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "THE CIRCUIT BREAKS AT ONE OF THE PLASTIC CONNECTOR PIECES NEAR THE PATIENT". ALLEGED ISSUE REPORTED AS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE DEVICE INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE WAS NOT RETURNED AT THE TIME OF THIS REPORT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. IN ORDER TO PERFORM A PROPER AND THOROUGH INVESTIGATION, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THIS COMPLAINT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. ROOT CAUSE IS UNKNOWN. NO CORRECTIVE ACTION CAN BE ESTABLISHED. IF DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE CIRCUIT BREAKS AT ONE OF THE PLASTIC CONNECTOR PIECES NEAR THE PATIENT". ALLEGED ISSUE REPORTED AS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331206 HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/18 IN SET, TUBING AND SUPPORT,VENTILATOR BZO TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1