BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON DUAL LIMB HEATED NEONATAL CIRCUIT

    MDR report key: 2002281 · Received January 25, 2011

    Report

    Report Number
    3004365956-2011-00052
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RETURNED IN TIME FOR THIS REPORT. INVESTIGATION IS INCOMPLETE. A F/U REPORT WILL SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CAP ON THE PORT AT THE WYE WAS CRACKED, CAUSING THE CIRCUIT TO NOT PASS THE LEAK TEST. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON DUAL LIMB HEATED NEONATAL CIRCUIT VENTILATOR CIRCUIT BTT TELEFLEX MEDICAL NA 02C1003697

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK