BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD UROLOGICAL CATHETER

    MDR report key: 746369 · Received October 6, 2005

    Report

    Report Number
    MW1036876
    Event Type
    Injury
    Date Received
    October 6, 2005
    Date of Event
    September 7, 2005
    Report Date
    October 6, 2005
    Manufacturer
    BARD. C.R. BARD, INC.
    Product Code
    FEW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF EMPYEMA HAD 3 MALECOT CATHETERS INSERTED FOR OPTIMAL DRAINAGE. THE PATIENT HAD A PARTIAL RIB RESECTION AS WELL. SIX WEEKS AND 4 DAYS LATER THE PATIENT RETURNED TO THE CLINIC TO HAVE THE DRAINS REMOVED. THE TIP OF THE LAST CATHETER TO BE REMOVED REMAINED INSIDE THE PATIENT CONFIRMED BY THE CAT SCAN. THE PATIENT WAS TAKEN TO THE OR THE NEXT DAY AND THE RETAINED FOREIGN OBJECT WAS SURGICALLY REMOVED. PLEASE NOTE: THE SURGEON STATES THAT HE APPLIED 'NORMAL'; TRACTION WHEN PULLING CATHETERS OUT. TRACTION WAS EQUAL FOR ALL THREE. ALSO, UPON REVIEW OF THE TIP - IT WAS SUCH A 'CLEAN' BREAK AT THE BENDABLE PORTION OF THE MALECOT TIP THAT IT LOOKED CUT BUT WAS NOT. THERE ARE 4 'SPOKES' THAT CREATE A FLANGE APPEARANCE. THREE OF THE 4 GAVE WAY RIGHT AT THE 'BENT' PORTION. THE 4TH 'SPOKE' HELD. PICTURES TAKEN OF CATHETER TIP FOR FUTURE REFERENCE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD UROLOGICAL CATHETER MALECOT FEW BARD. C.R. BARD, INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R