BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON 780-07 CIRCUIT W/ COLUMN

    MDR report key: 6138105 · Received December 1, 2016

    Report

    Report Number
    3004365956-2016-00445
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 8, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER, BUT THE INVESTIGATION IS STILL IN PROGRESS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED, AND IS NOT KNOWN AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THERE WAS A CRACK ON THE PRIMARY FEMALE PORT OF THE CONNECTOR. THE REPORTED COMPLAINT OF A CRACKED WYE CONNECTOR WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE RETURNED CONNECTOR WAS CONFIRMED TO BE CRACKED AS A RESULT OF A SINGLE CRACK RUNNING PARALLEL TO THE PRIMARY FEMALE CONNECTOR. ALL CIRCUITS ARE 100% INSPECTED FOR DAMAGE AT THE TIME OF MANUFACTURING SO IT IS UNLIKELY THAT THIS DEFECT WAS PRESENT AT THAT TIME. BASED UPON THE TIME OF DISCOVERY AND THE DAMAGE OBSERVED ON THE RETURNED SAMPLE, IT WAS DETERMINED THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE A "CRACK AT THE WYE" ON A NEONATE CIRCUIT. THE CRACK WAS NOTICED AT THE 30 DAY CIRCUIT CHANGE". ALTHOUGH THE REPORTED DEFECT WAS DETECTED DURING USE, THERE WAS NO PATIENT INJURY OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE A "CRACK AT THE WYE" ON A NEONATE CIRCUIT. THE CRACK WAS NOTICED AT THE 30 DAY CIRCUIT CHANGE". ALTHOUGH THE REPORTED DEFECT WAS DETECTED DURING USE, THERE WAS NO PATIENT INJURY OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788871 HUDSON 780-07 CIRCUIT W/ COLUMN HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1