BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL HEATED-WIRE CIRCUIT, DUAL LIMB

    MDR report key: 3116213 · Received May 13, 2013

    Report

    Report Number
    3004365956-2013-00134
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 17, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL,DIMENSIONAL AND FUNCTIONAL INVESTIGATION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED AT THE TIME OF THIS REPORT. THE ASSEMBLY PROCESS AND MANUFACTURING PROCEDURE FOR CATALOG # 780-15 WERE REVIEWED AND NO FINDINGS THAT CAN POTENTIALLY RELATE TO THE REPORTED ISSUE WERE FOUND. A DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED SINCE THE LOT NUMBER PROVIDED (00236) IS INVALID. THE MANUFACTURING DATE OF THE PRODUCT IN QUESTION COULD NOT BE DETERMINE THE ROOT CAUSE. HOWEVER, BASED ON SIMILAR COMPLAINTS THE ROOT CAUSE COULD NOT BE RELATED WITH THE CRACK ON THE PRESSURE PORT CAP (P/N MP-0514) BUT IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO CONFIRM IT. FOR CORRECTIVE AND PREVENTIVE ACTIONS CAPA (B)(4) WAS OPENED. TELEFLEX WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS VIA PERIODIC REVIEWS TO EVALUATE IF ANY TRENDS EXIST.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CAPS ON THE PRESSURE LINE OF THE CIRCUIT, BY THE PATIENT WYE, IS CRACKED. THE CIRCUIT WILL NOT PASS THE SST ON THE 840 VENTILATOR. NO PATIENT INJURY/ INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210914 HUDSON NEONATAL HEATED-WIRE CIRCUIT, DUAL LIMB HEATED WIRE CIRCUIT BZO TELEFLEX MEDICAL 00236

    Patients

    Seq Age Sex Outcome Treatment
    1 840 VENTILATOR