BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 325990 · Received April 5, 2001

    Report

    Report Number
    MW1021574
    Event Type
    Injury
    Date Received
    April 5, 2001
    Date of Event
    March 16, 2001
    Report Date
    April 3, 2001
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BARD OPTI FLOW DUAL LUMEN CATHETER WAS INSERTED FOR CHRONIC RENAL FAILURE FOR HEMODIALYSIS. PT DISCHARGED, DOING FINE. ADMITTED 3 MOS LATER, WITH SOB AND A WORKUP ENSUED. DURING THE WORKUP THE CHEST X-RAY REVEALED THE TIP OF CATHETER HAD FRACTURED AND EMBOLIZED TO THE RIGHT PULMONARY ARTERY. A CLINICAL DECISION WAS MADE TO REMOVE THE FRAGMENT. THE MFR WAS CONTACTED, HOSP WAS INFORMED AT THAT TIME THERE WAS A RECALL WHICH THEY WERE NEVER INFORMED OF. ALL PDK REMOVED. PT WAS INFORMED AND IS SUBSEQUENTLY DOING FINE. TIP RETAINED WICH WAS REMOVED. OTHER PIECE OF CATHETER DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14802 BARD ACCESS SYSTEMS OPTI-FLOW DUAL LUMEN CATHETER MPB BARD ACCESS SYSTEMS OPTI-FLOW CATHETER PCM 22KJM002, 22EKY002, (MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R 5-6 OTHER TIMES AND THEY HAVE RECALLED THIS| PRODUCT.| REP NOTIFIED AND INSTRUCTED HOSP THIS HAS OCCURRED