BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6663597 · Received June 23, 2017

    Report

    Report Number
    3004365956-2017-00257
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Date of Event
    June 12, 2017
    Report Date
    June 12, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE DEVICE INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE WAS NOT RETURNED AT THE TIME OF THIS REPORT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED AT THIS TIME. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE SOURCE OF THE ALLEGED DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. HOWEVER, CURRENT PRODUCTION OF 780-07 WAS VERIFIED ACCORDING TO OUR SPECIFICATION AND NO ISSUES WERE DETECTED THAT COULD LEAD TO THE ALLEGED DEFECT REPORTED. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS REPORT WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE SMALL PLASTIC CONNECTOR AT THE WYE IS COMING LOOSE AND FALLS OUT OF THE CIRCUIT CREATING A LEAK IN THE CIRCUIT." ALLEGED MALFUNCTION IS REPORTED AS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443981 HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/18 IN SET,TUBING SUPP. VENT W/ HARNESS BZO TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1