BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q, SILVERSOAKER 5IN:400ML DUAL 2+2 ML/HR

    MDR report key: 3240333 · Received July 18, 2013

    Report

    Report Number
    2026095-2013-00125
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 21, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: IT IS REPORTED THAT THE SAMPLE DEVICE WILL BE AVAILABLE FOR RETURN, AT THIS TIME IT IS PENDING RETURN TO THE MFR. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED, AND THE DEVICE PASSED ALL MFG SPECS PRIOR TO RELEASE. CONCLUSIONS: A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. 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: UNK. FILL VOLUME: UNK. FLOW RATE: UNK. PROCEDURE: ABDOMINOPLASTY. CATHPLACE: UNK. DATE OF SURGERY: (B)(6) 2013. IT WAS REPORTED THAT A PT'S CATHETER BROKE. THE PT NOTICED THAT ONE OF THE CATHETERS HAD JUST CRACKED OFF INSIDE OF HER. THE SECOND CATHETER CAME OUT JUST FINE. THE PT WENT TO THE HOSPITAL AND AN X-RAY WAS TAKEN, BUT THE CATHETER COULD NOT BE SEEN. EVENT DATE IS UNK AT THIS TIME. NOTE: THE REPORTED LOT NUMBER GIVEN BY THE FACILITY 0200668651 BELONGS TO THE KIT (PM028-A). THE CATHETER'S LOT NUMBER AND MFG DATE ARE PROVIDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334176 ON-Q, SILVERSOAKER 5IN:400ML DUAL 2+2 ML/HR CATHETER BSO I-FLOW, LLC PM028-A 0200640680

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other