BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2201505 · Received August 3, 2011

    Report

    Report Number
    3004365956-2011-00294
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Report Date
    July 21, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE CIRCUITS FAILED THE LEAK TEST DURING THE DIAGNOSTIC PRE-TEST. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN NEONATAL CIRCUIT BZO TELEFLEX MEDICAL NA 02C1101836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA