BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 2232613 · Received August 26, 2011

    Report

    Report Number
    1820334-2011-00491
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 9, 2011
    Manufacturer
    COOK INC
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO INFO WAS PROVIDED REGARDING OUTCOME OF THE PT. (B)(4) - SEPARATES IS NOT LABELED. THE COMPLAINT DEVICE WAS RETURNED IN A USED AND CONTAMINATED CONDITION. SEPARATION OF THE HUB WAS CONFIRMED. A SMALL PORTION OF THE FLARE REMAINED WITH THE SHAFT AND THE REMAINDER WAS STILL TRAPPED BETWEEN THE CAP AND ADAPTER. THE REST OF THE CATHETER WAS UNREMARKABLE. APPROPRIATE DESIGN CONTROL ACTIVITIES HAVE BEEN COMPLETED. AN IFU IS PROVIDED WITH THIS DEVICE. THE ROOT CAUSE OF THE SEPARATION IS UNK. UNFORTUNATELY, NO LOT NUMBER WAS PROVIDED, THUS THE DATE OF MANUFACTURE CANNOT BE DETERMINED. IT IS POSSIBLE THAT THE CATHETER WAS EXPOSED TO FORCES ABOVE WHAT WOULD BE EXPECTED UNDER TYPICAL CIRCUMSTANCES. ADDITIONALLY, RECENT TENSILE TESTING OF SIMILAR DEVICES DEMONSTRATED THAT THE CATHETERS MET ALL FORCE AT BREAK REQUIREMENTS AS SPECIFIED IN (B)(4). ALTHOUGH NOT AN OUTPUT OF THIS INVESTIGATION, IN AN EFFORT TO MINIMIZE REPORTS OF THIS NATURE, AN ENGINEERING PROJECT WAS INITIATED WHICH INCLUDES ADDITIONAL PROCESS CONTROLS AND DESIGN IMPROVEMENTS. THIS PROJECT WAS COMPLETED (B)(6) 2010. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    THE CHEST TUBE BECAME DISLODGED FROM THE MFR'S HUB. EACH END OF THE CONNECTION WAS CLEANED WITH CHLORAPREP AND PUT BACK TOGETHER AND REINFORCED WITH STERI STRIPS. THE CHEST TUBE SEPARATED AGAIN AND THE CHEST TUBE WAS REPLACED. THE CHEST TUBE HAD BEEN CONNECTED TO WATER SEAL AT THE TIME OF THE CATHETER SEPARATION. AIR REACCUMULATED AND THE CHEST TUBE WAS REPLACED. NO INFO WAS PROVIDED REGARDING PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET KDQ BOTTLE, COLLECTION, VACUUM KDQ COOK INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Required Intervention