BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q SS CATHETER

    MDR report key: 3057500 · Received April 8, 2013

    Report

    Report Number
    2026095-2013-00059
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WILL NOT BE RETURNED. RESULTS: IF ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. THE DIRECTIONS FOR USE ((B)(4)) PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. IT ALSO CONTAINS A CAUTION OF, "DO NOT CUT OR FORCEFULLY REMOVE CATHETER." I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ((B)(4)) IN ORDER TO PREVENT OR DECREASE CATHETER BREAKS, ENTITLED, "TIPS ON PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM." I-FLOW IS CURRENTLY CONDUCTING AN INVESTIGATION ON CATHETER BREAKS UNDER INVESTIGATION NUMBER (B)(4).

    Description of Event or Problem · 1

    DRUG/DILUENT: UNK. FILL VOLUME: UNK. FLOW RATE: 5ML. PROCEDURE: UNK. CATHPLACE: IN ABDOMEN ABOVE BELLY BUTTON. CUSTOMER REPORTED CATHETER BREAK. AFTER REMOVAL OF CATHETER, IT WAS NOTICED THAT NO BLACK MARK WAS NOTED. ROUGHLY 3 - 4 INCHES BROKE OFF. CATHETER FRAGMENT REMOVAL WAS DONE ON (B)(6) 2013. DATE OF SURGERY: (B)(6) 2013. THE PRODUCT WAS REPORTED TO BE LOT 0200794893, MODEL PM026-A, AND PRODUCT NUMBER 101371900. CATHETER INFORMATION UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144415 ON-Q SS CATHETER CATHETER BSO I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR