BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q CATHETER

    MDR report key: 2230671 · Received August 12, 2011

    Report

    Report Number
    2026095-2011-00209
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 14, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE RECEIVED FOR EVALUATION AND INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. THE DIRECTIONS FOR USE (DFU) (1307122, REV. A) PROVIDE CAUTIONS THAT STATES "DO NOT CUT OR FORCEFULLY REMOVE THE CATHETER." RESULTS: WITHOUT THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. IF ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT OR SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PROCEDURE: PERI-VAGINAL DEFECT REPAIR. CATHPLACE: DUAL, ABDOMEN, EXTRA PERITONEAL. SURGERY DATE: (B)(6), 2011. SURGEON CALLED HOTLINE TO REPORT THAT ONE OF THE CATHETERS WAS CUT WITH SCISSORS DURING REMOVAL BY RN AND IS RETAINED IN THE PATIENT'S ABDOMEN. ALTHOUGH CT SCAN AND ULTRASOUND SHOWED NO CATHETER, SURGEON AND PATIENT KNOW CATHETER FRAGMENT IS IN THE PATIENT BECAUSE WHEN THE CATHETER WAS CUT, THE REMAINDER RETRACTED INTO THE PATIENT'S BODY. SURGEON PLANS TO ATTEMPT REMOVAL OF THE CATHETER FRAGMENT ONCE THE PATIENT HAS HAD 6 WEEKS TO HEAL. PATIENT IS STABLE. DATE OF EVENT: (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q CATHETER CATHETER MEB I-FLOW CORP. UNK ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other