BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THAL-QUICK CHEST TUBE SET

    MDR report key: 6092143 · Received November 10, 2016

    Report

    Report Number
    1820334-2016-01257
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 10, 2016
    Report Date
    April 19, 2017
    Manufacturer
    COOK INC
    Product Code
    GBX
    UDI-DI
    00827002067875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD (DHR), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS, AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE DISTAL WELD CONNECTION OF THE DEVICE SEPARATED FROM THE COIL AND SAFETY WIRE. COIL ELONGATION WAS PRESENT, WITH APPROXIMATELY 22.5 CM OF THE COIL ELONGATED. THE SAFETY WIRE WAS CONFIRMED TO HAVE PROTRUDED THROUGH THE COIL. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE LOT MET ALL FINISHED GOODS RELEASE CRITERIA. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PER THE MW (B)(4), REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS AND CUSTOMER RELATIONS, THE MANUFACTURER WAS INFORMED THAT THE NEONATAL NURSE PRACTITIONER WAS INSERTING A CHEST TUBE WHEN THE GUIDE WIRE BECAME FAULTY AND STARTED TO UNRAVEL IN THE MIDDLE OF THE WIRE PATIENT TOLERATED PROCEDURE WITH NO HARM AND NO ADVERSE EFFECTS. NO SECTION OF THE DEVICE OF THE DEVICE REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745323 THAL-QUICK CHEST TUBE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A 00827002067875

    Patients

    Seq Age Sex Outcome Treatment
    1