BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q SILVERSOAKER 10INCH (25CM)

    MDR report key: 2926389 · Received January 16, 2013

    Report

    Report Number
    2026095-2013-00015
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 21, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE HAS NOT BEEN REC'D BUT WAS REPORTED TO BE AVAILABLE. RESULTS: RESULTS ARE PENDING THE SAMPLE EVAL AND TESTING AT THIS TIME. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN REC'D AND A F/U REPORT WILL BE FILED. THE DIRECTIONS FOR USE (DFU) (1307112, REV. A) PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. THE DIRECTIONS FOR USE STATES, "IF RESISTANCE IS ENCOUNTERED OR CATHETER STRETCHES, STOP. CONTINUED PULLING COULD BREAK THE CATHETER. IT'S ADVISABLE TO WAIT 30 TO 60 MINS AND TRY AGAIN. THE PT'S BODY MOVEMENTS MAY RELIEVE THE CATHETER TO ALLOW EASIER REMOVAL. DO NOT CUT OR FORCEFULLY REMOVE THE CATHETER. IT ALSO CONTAINS CAUTION OF "DO CUT OR FORCEFULLY REMOVE CATHETER." I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN (1303971, REV. B) IN ORDER TO PREVENT OR DECREASE CATHETER BREAKS ENTITLED: "TIPS FOR PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM." INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: 0.5% ROPIVACAINE, FILL VOLUME: 400ML, FLOW RATE: 4ML/HR, PROCEDURE: THIGH PLASTY, CATHPLACE: SUBCUTANEOUS, MEDIAL THIGH. PHYSICIAN REPORTED THAT A CATHETER APPEARED NICKED (CLEAN CUT). THE PHYSICIAN REPORTED THAT A CLOSED- SUCTION DRAIN COULD HAVE INTERFERED WITH THE CATHETER. AFTER SEEING THE CATHETER, THE PHYSICIAN ESTIMATES THAT A 6" SEGMENT BROKE OFF. THE CATHETER SEGMENT WAS NOT REMOVED. THE PT IS RECOVERING WELL. (ADD'L INFO: ON-Q PUMP MODEL: PM048-A, CATALOG # 101372300, LOT # 0200732196).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24151 ON-Q SILVERSOAKER 10INCH (25CM) CATHETER BSO I-FLOW, LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other