BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q SILVER SOAKER CATHETER

    MDR report key: 2800943 · Received October 18, 2012

    Report

    Report Number
    2026095-2012-00249
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 20, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE WAS RECEIVED FOR EVALUATION AND INVESTIGATION. RESULTS: WITHOUT THE ACTUAL PRODUCT, A COMPLETE INVESTIGATION CANNOT BE CONDUCTED. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. IF ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS RECEIVED, WE WILL REOPEN THIS COMPLAINT. THE DIRECTIONS FOR USE (DFU) (1307112, REV. A) 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 (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." I-FLOW IS FURTHER INVESTIGATING THIS FAILURE MODE UNDER EVENT # (B)(4). INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AN APPROPRIATE. OUR CONTACT PERSON FOR THE HOSPITAL REGARDING THIS INCIDENT: (B)(6).

    Description of Event or Problem · 1

    DRUG/DILUENT: 0.2% ROPIVACAINE. FILL VOLUME: NOT APPLICABLE. FLOW RATE: NOT APPLICABLE. PROCEDURE: ROTATOR CUFF REPAIR. CATHPLACE: SUBCROMIAL SPACE. CATHETER BROKE INSIDE THE PT DURING REMOVAL, THE AMOUNT OF RESISTANCE MET ON A SCALE OF 1 - 5 WAS A 4. THE CATHETER SEGMENT WAS APPROXIMATELY 2 INCHES AND WAS SURGICALLY REMOVED ON THE (B)(6). THE REPORTED PUMP MODEL USED WITH THIS CATHETER IS PM014-A. PT STATUS IS GOOD. PT CONTACT: YES. MEDICAL INTERVENTION: YES - SURGICALLY REMOVED. DATE OF INITIAL SURGERY: (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other