BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q EXPANSION KIT: SILVERSOAKER 10 IN

    MDR report key: 3121886 · Received May 15, 2013

    Report

    Report Number
    2026095-2013-00094
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    April 15, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WILL NOT BE RETURNED. A DEVICE HISTORY REVIEW IS PENDING INVESTIGATION AT THIS TIME. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNK, FILL VOLUME: NOT APPLICABLE, FLOW RATE: NOT APPLICABLE, PROCEDURE: SMALL BOWEL RESECTION, CATHPLACE: UNK. PLEASE REF MDR 2026095-2013-00088/13-00445 (PUMP), ALSO 2026095-2013-00093/13-00557 (FLUID TUNNELER AND SHEATH). THE CLINICAL EDUCATOR AT (B)(6) MEDICAL CENTER: REPORTED THAT THEY HAD AN INFECTION FOLLOWING A SURGICAL PROCEDURE WHERE AN ON-Q WAS USED. IT WAS REPORTED THAT THE DEVICE MAY HAVE BEEN A CONTRIBUTING FACTOR. I-FLOW COMMENTS: ADD'L INFO WAS RECEIVED ON (B)(6) 2013, WITH REGARDS TO 2 (TWO) ADD'L I-FLOW PRODUCTS USED IN THIS INCIDENT. THE REPORTED LOT NUMBER (142609) BELONGS TO THE (B)(4) AS A WHOLE KIT, WITHIN THAT KIT THERE ARE TWO CATHETER LOT NUMBERS (143863 AND 133622) IT IS UNK WHAT LOT NUMBER THE REPORTED CATHETER IN THIS INCIDENT BELONGS TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215024 ON-Q EXPANSION KIT: SILVERSOAKER 10 IN CATHETER BSO I-FLOW, LLC PM040-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other