BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAYNE PNEUMOTHORAX TRAY

    MDR report key: 5653810 · Received May 13, 2016

    Report

    Report Number
    1820334-2016-00329
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Report Date
    April 22, 2016
    Manufacturer
    COOK INC
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO) UNKNOWN AS NOT PROVIDED. OUTCOMES ATTRIBUTED TO ADVERSE EVENTS) UNKNOWN AS NOT PROVIDED. COMMON DEVICE NAME) JOL, CATHETER AND TIP, SUCTION. LOT # UNKNOWN AS IT WAS NOT PROVIDED. OCCUPATION) UNKNOWN AS IT WAS NOT PROVIDED. AWARENESS DATE) UNKNOWN AS IT WAS NOT PROVIDED. APPROX. AGE OF DEVICE) UNKNOWN AS NO LOT # WAS PROVIDED. (B)(4). DEVICE MANUFACTURE DATE) UNKNOWN AS NO LOT # WAS PROVIDED. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWING, DIMENSIONAL VERIFICATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER IS NOT KNOWN, ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH AN IFU THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: "REMOVE THE WIREGUIDE AND CATHETER OBTURATOR. ATTACH CATHETER TO CONNECTING TUBE WITH STOPCOCK, AND COOK CHEST DRAIN VALVE." STEP 10, "CONFIRM CATHETER PLACEMENT BY VALVE MOVEMENT AND FLUOROSCOPIC OR ROENTGENOGRAPHIC VERIFICATION." THE ROOT CAUSE OF THIS CASE IS FAILURE TO FOLLOW THE IFU'S INSTRUCTION TO REMOVE THE OBTURATOR. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    AFTER PLACING THE CHEST TUBE, THE INNER OBTURATOR WAS NOT REMOVED AND THE CONNECTING TUBING WAS ATTACHED TO THE END OF THE OBTURATOR. THIS WAS DISCOVERED THE DAY AFTER PLACEMENT AND THE OBTURATOR WAS REMOVED AT THAT POINT. THE PATIENT IS IN STABLE CONDITION AND DID NOT EXPERIENCE ADVERSE EFFECTS.

    Description of Event or Problem · 1

    AFTER PLACING THE CHEST TUBE, THE INNER OBTURATOR WAS NOT REMOVED AND THE CONNECTING TUBING WAS ATTACHED TO THE END OF THE OBTURATOR. THIS WAS DISCOVERED THE DAY AFTER PLACEMENT AND THE OBTURATOR WAS REMOVED AT THAT POINT. THE PATIENT IS IN STABLE CONDITION AND DID NOT EXPERIENCE ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310184 WAYNE PNEUMOTHORAX TRAY JOL CATHETER AND TIP, SUCTION JOL COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1