BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MALECOT DRAIN

    MDR report key: 790772 · Received November 22, 2006

    Report

    Report Number
    1018233-2006-00199
    Event Type
    Injury
    Date Received
    November 22, 2006
    Date of Event
    September 7, 2005
    Report Date
    November 22, 2006
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFO WAS PROVIDED FOR EVAL. ACCORDING TO THE REPORTER, THE SAMPLE IS MISSING AND CANNOT BE LOCATED. A REVIEW OF THE MANUFACTURING PROCESS SHOWED THERE ARE IN-PROCESS CONTROLS DESIGNED TO MINIMIZE DEFECTS FROM GETTING INTO THE FIELD THAT INCLUDE A 100% VISUAL INSPECTION. IN ADDITION, DEFECT AWARENESS MEETINGS ARE HELD WHERE OPERATORS ARE INFORMED OF REPORTED DEFECTS AND ARE MADE AWARE OF HOW THEIR SPECIFIC OPERATION CAN AFFECT PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH LEFT LOWER LOBE PNEUMONIA WITH A HISTORY OF EMPHYSEMA HAD THREE MALECOT CATHETERS INSERTED ON 07/22/05 FOR OPTIMAL DRAINAGE. THE PT HAD A PARTIAL RIB RESECTION AS WELL. THE PT WAS DISCHARGED HOME AND ON 09/07/05 AND SIX WEEKS AND FOUR DAYS LATER, THE PT RETURNED TO THE CLINIC TO HAVE THE DRAINS REMOVED. THE TIP OF THE LAST CATHETER TO BE REMOVED REMAINED INSIDE THE PT AND WAS CONFIRMED BY CAT SCAN. THE PT WAS TAKEN TO THE OPERATING ROOM THE NEXT DAY AND THE RETAINED FOREIGN OBJECT WAS SURGICALLY REMOVED VIA AN INCISION TO RETRIEVE THE TIP. 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 FOUR SPOKES THAT CREATE A FLANGE APPEARANCE. THREE OF THE FOUR SPOKES GAVE WAY RIGHT AT THE BENT PORTION. THE FOURTH SPOKE HELD. ADDITIONAL INFO HAS BEEN REQUESTED BUT HAS NOT BEEN REC'D. IT IS UNCLEAR HOW THE FOURTH SPOKE COULD HAVE HELD YET THE TIP OF THE CATHETER REMAINED INSIDE THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention