BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7377680 · Received March 28, 2018

    Report

    Report Number
    3004365956-2018-00093
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 13, 2018
    Report Date
    March 16, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION: A MEDWATCH WAS RECEIVED FROM THE USER FACILIT: UF# (B)(4). PER MEDWATCH REPORT: MALE BABY 28 WEEK GESTATION 1190 GRAMS; DIAGNOSED WITH PREMATURITY AND RESPIRATORY DISTRESS BEING VENTILATED. CORRECTED DATA: SECTION B.3.: DATE OF EVENT CORRECTED TO (B)(6) 2018. ONE INSPIRATORY LEG OF THE INFANT BREATHING CIRCUIT WAS RECEIVED FOR INVESTIGATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CLEAR PLASTIC TEMPERATURE PROBE PORTAL WAS BROKEN. BASED ON A PRELIMINARY INVESTIGATION, THE BREAK IN THE TEMPERATURE PROBE PORTAL IS AT A SONIC WELD. THE PROBABLE CAUSE IS UNKNOWN AT THIS TIME. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. A CONCLUSION CODE COULD NOT BE FOUND AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THE "CIRCUIT CAME APART ON A PATIENT AT THE TEMPERATURE PROBE SITE. IT LOOKS LIKE IT IS AN AREA WHERE THE TWO PLASTIC PIECES AR E GLUED TOGETHER. THIS PATIENT WAS ONLY ON THE VENT WITH THIS CIRCUIT FOR 3 DAYS". IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE. PATIENT CONDITION REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (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. THE DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. TO PERFORM AN INVESTIGATION TO CONFIRM THE ALLEGED DEFECT AND DETERMINE A ROOT CAUSE, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. ROOT CAUSE IS UNKNOWN. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS TIME. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS REPORT WILL BE UPDATED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE "CIRCUIT CAME APART ON A PATIENT AT THE TEMPERATURE PROBE SITE. IT LOOKS LIKE IT IS AN AREA WHERE THE TWO PLASTIC PIECES AR E GLUED TOGETHER. THIS PATIENT WAS ONLY ON THE VENT WITH THIS CIRCUIT FOR 3 DAYS". IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222566 HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/18 IN SET, TUBING AND SUPPORT,VENTILATOR BZO TELEFLEX MEDICAL 74G1701637

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA