BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1594776 · Received January 29, 2010

    Report

    Report Number
    2026095-2010-00008
    Event Type
    Other
    Date Received
    January 29, 2010
    Date of Event
    January 1, 2010
    Report Date
    January 7, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. NO SAMPLE WAS RECEIVED FOR EVALUATION AND INVESTIGATION, BUT PHOTOS OF THE SHEATH WERE PROVIDED BY THE FACILITY. THE INSPECTION OF THE PHOTOGRAPHS FOUND ONE SIDE OF THE SHEATH TO BE APPROXIMATELY 1" SHORTER THAN THE OTHER. THE SHEATH APPEARED TO HAVE SPLIT PROPERLY. NO SPECIFIC KNOWLEDGE OF THE PROCEDURE OR REMOVAL OF THE SHEATH WAS PROVIDED. THE DIRECTIONS FOR USE (1306078, REV. A) STATES: "WHILE HOLDING THE CATHETER TIP, WITHDRAW SHEATH COMPLETELY FROM PUNCTURE SITE PRIOR TO SPLITTING TO AVOID SHEATH BREAKING OFF IN PATIENT, SPLIT SHEATH AND PEAL AWAY FROM CATHETER." A WARNING IS ALSO INCLUDED, STATING "DO NOT REINSERT A PARTIALLY OR COMPLETELY WITHDRAWN NEEDLE AS THIS CAN DAMAGE THE SHEATH AND BREAK OFF IN PATIENT UPON SHEATH REMOVAL." NO DETERMINATION CAN BE MADE AS TO WHAT MAY HAVE OCCURRED WITH THIS PRODUCT AT THIS TIME. A REVIEW OF THE LOT HISTORY FOUND THIS TO BE THE ONLY COMPLAINT FOR THE REPORTED LOT. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    SHEATH BROKE OFF IN PATIENT'S FOOT DURING SURGERY. PART WAS REMOVED. PHOTOS TAKEN AND SUBMITTED. LOT NUMBER PROVIDED IS MOST LIKELY THE LOT USED, BUT CANNOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER BSO I-FLOW CORPORATION PM012-A 952436

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other