BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 6206225 · Received December 27, 2016

    Report

    Report Number
    1820334-2016-01613
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Report Date
    April 18, 2017
    Manufacturer
    COOK INC
    Product Code
    GBX
    UDI-DI
    00827002557239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WIRE GUIDE WAS RETURNED IN DAMAGED, USED CONDITION. EXAMINATION REVEALED THE INNER MANDRIL WIRE WAS BROKEN IN THE MIDDLE. THE COIL ALONG THIS SECTION OF THE WIRE WAS ELONGATED AND UNCOILED, BUT STILL ATTACHED. THE TIP WELDS WERE PRESENT AND UNDAMAGED. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE SIGNS OF STRETCHING IN THE COIL INDICATE THAT THE WIRE WAS MOST LIKELY CAUGHT WITHIN THE CATHETER LUMEN, PINCHED ON THE DISTAL END AND STRETCHED UNTIL IT SNAPPED. HOWEVER, WITHOUT FURTHER INFORMATION WE ARE UNABLE TO DETERMINE IF THE WIRE BREAKING WAS CAUSED BY EXCESSIVE PRESSURE, PATIENT ANATOMY, OR MANUFACTURING. THE ROOT CAUSE IN INCONCLUSIVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(4).THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHEST TUBE PLACEMENT PROCEDURE, THE GUIDE WIRE BROKE WHILE TRYING TO REMOVE FROM PIGTAIL. A NEW KIT WAS OPENED AND THE PROCEDURE HAD TO BE STARTED OVER FROM THE BEGINNING. NO HARM TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856226 FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A 00827002557239

    Patients

    Seq Age Sex Outcome Treatment
    1