BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7573307 · Received June 6, 2018

    Report

    Report Number
    3004365956-2018-00195
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    April 19, 2018
    Report Date
    June 4, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    PMA / PMN Number
    K903083
    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 04/17/2018 UNDER MDR# 3004365956-2018-00114; 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).

    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
    415530 HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/18 IN SET, TUBING AND SUPPORT, VENTI BZO TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1