BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q EXPANSION KIT: SILVER SOAKER 5IN (12.5CM)

    MDR report key: 2445765 · Received February 7, 2012

    Report

    Report Number
    2026095-2012-00016
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    December 31, 2011
    Report Date
    January 2, 2012
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN REC'D, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: W/O THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN REC'D AND A F/U REPORT WILL BE FILED. I-FLOW PROVIDES A "CAUTION" ON ITS DFU WHICH STATES THE FOLLOWING: IF RESISTANCE IS ENCOUNTERED OR CATHETER STRETCHES, STOP. CONTINUED PULLING COULD BREAK THE CATHETER. IT'S ADVISABLE TO WAIT 30 TO 60 MINS AND TRY AGAIN. THE PT'S BODY MOVEMENTS MAY RELIEVE THE CATHETER TO ALLOW EASIER REMOVAL. IF CATHETER IS STILL DIFFICULT TO REMOVE, AN X-RAY IS RECOMMENDED. DO NOT CUT OR FORCEFULLY REMOVE CATHETER. AFTER REMOVAL, CHECK DISTAL END OF CATHETER FOR THE BLACK MARKING TO ENSURE ENTIRE CATHETER WAS REMOVED.

    Description of Event or Problem · 1

    DRUG/DILUENT: BUPIVACAINE 0.5%. FILL VOLUME: 270 ML. FLOW RATE: 4 ML/HR. PROCEDURE: ROUX-N-Y. CATHPLACE: EPIGASTRIC AREA. IT WAS REPORTED THAT DURING THE REMOVAL OF THE CATHETER, THERE WAS SOME RESISTANCE AROUND THE DERMABOND INCISION SITE. THE CATHETER CAME OUT, BUT THERE WAS CONCERN THAT A PIECE MIGHT OF BROKEN INSIDE. THE CATHETER WAS USED WITH A P270X4D PUMP. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q EXPANSION KIT: SILVER SOAKER 5IN (12.5CM) CATHETER BSO I-FLOW CORPORATION PM020-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other