BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER, SILVERSOAKER 5IN

    MDR report key: 2083073 · Received April 1, 2011

    Report

    Report Number
    2026095-2011-00094
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 5, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE RECEIVED FOR EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE INFORMATION PROVIDED STATED THAT THE CATHETER MET SOME RESISTANCE DURING REMOVAL AND FEELS IT MAY HAVE CAUGHT A STITCH. THE DIRECTIONS FOR USE (DFU) (1304459, REV.C) 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 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." (1303971, REV. B). IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO 10993-1 TISSUE COMPATIBILITY GUIDELINES FOR IMPLANTATION OF UP TO 30-DAYS; COMPLICATIONS MAY ARISE IF A CATHETER (OR PORTION THEREOF) IS LEFT IN THE BODY FOR LONGER THAN THIS PERIOD OF TIME. RESULTS: WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. IF ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (DRUG/DILUENT: UNKNOWN). (PROCEDURE: C-SECTION). (CATHPLACE: UNDER FASCIA). CATHETER BROKE DURING REMOVAL. MET SOME RESISTANCE, BUT SURGEON FEELS IT MAY HAVE CAUGHT A STITCH. SURGEON'S PARTNER ACTUALLY REMOVED CATHETER. SEGMENT STILL IN PATIENT. PATIENT DOING WELL. CATHETER GIVEN TO RISK MANAGEMENT, MAY NOT BE RETURNED. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER, SILVERSOAKER 5IN CATHETER MEB I-FLOW CORP. PM020-A 062077

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR