BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CIRCUIT, PEDIATRIC, SINGLE HTD LIMB W/WAT

    MDR report key: 3207341 · Received July 1, 2013

    Report

    Report Number
    3004365956-2013-00226
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 17, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) PICTURE RELATED WITH THE CUSTOMER COMPLAINT # (B)(4) WAS RECEIVED FOR ANALYSIS. IT WAS VISUALLY INSPECTED AND WAS DETECTED THAT THE COMPONENT OF THE PICTURE CORRESPONDING TO THE P/N MP-0514 AND THAT COMPONENT IS NOT USED ON THE CATALOG NUMBER 780-23. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE ASSEMBLY PROCESS AND MANUFACTURING PROCEDURES FOR CATALOG# 780-23 WERE REVIEWED AND NO FINDINGS THAT AN POTENTIALLY RELATE TO THE REPORTED ISSUE WERE FOUND. A DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED BASED ON THE PICTURE RECEIVED BECAUSE IT WAS DETECTED THAT THE COMPONENT OF THE PICTURE CORRESPONDING TO THE P/N MP-0514 AND THAT COMPONENT IS NOT USED ON THE CATALOG NUMBER 780-23.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER REPORTS THAT THERE WAS A CRACK ON A CAP ON THE PRESSURE MONITORING LINE. NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298963 HUDSON CIRCUIT, PEDIATRIC, SINGLE HTD LIMB W/WAT HEATED WIRE CIRCUIT BZO TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1