BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMOTHORAX SET

    MDR report key: 2403682 · Received January 3, 2012

    Report

    Report Number
    MW5023724
    Event Type
    Injury
    Date Received
    January 3, 2012
    Date of Event
    November 5, 2011
    Report Date
    January 3, 2012
    Manufacturer
    COOK MEDICAL
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PLACEMENT OF PNEUMOTHORAX CATHETER BY PHYSICIAN USING A COOK CATHETER REFERENCE NUMBER (B)(4). IT WAS DISCOVERED DURING A SUBSEQUENT SURGICAL PROCEDURE ON (B)(6) 2011 THAT THE PROTECTIVE PLASTIC TIP TO THE CATHETER WAS NOT TAKEN OFF DURING PRIOR TO THE INITIAL PLACEMENT OF THE PNEUMOTHORAX CATHETER AND BECAME LODGED IN THE PLEURAL SPACE ADJACENT TO THE LUNG. IT IS BELIEVED THAT THE TIP BECAME DISLODGED FROM THE CATHETER WHEN THE CATHETER WAS REMOVED JUST PRIOR TO THE SURGERY. DURING THIS SURGERY, THE SURGEON SIMPLY REMOVED THE PLASTIC TIP WITH NO HARM TO THE PT. THE PLASTIC TIP MEASURES ABOUT 3/4 OF AN INCH LONG AND ABOUT 1/8 WIDE. PT WAS INFORMED OF FOREIGN BODY RETENTION AND MADE FULL RECOVERY FROM SURGICAL PROCEDURE. REASON FOR USE: PLEURAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMOTHORAX SET PNEUMOTHORAX SET KDQ COOK MEDICAL C-TPT-200 2711253

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability