BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER

    MDR report key: 2982330 · Received February 22, 2013

    Report

    Report Number
    2026095-2013-00033
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 24, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE CATHETER WILL NOT BE RETURNED TO I-FLOW FOR EVAL AND INVESTIGATION. RESULTS: AS NO LOT NUMBER WAS REPORTED, THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. CONCLUSIONS: IF ADD'L INFO IS RECEIVED, A F/U REPORT WILL BE FILED. INFO FROM THIS INCIDENT HAS BEEN 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: 0.2 % ROPIVACAINE. FILL VOLUME: NA. FLOW RATE: NA. PROCEDURE: PARAVERTEBRAL BLOCK PERFORMED ON (B)(6) 2012. CATHPLACE: UNK. SURGEON REPORTED CATHETER INSERTION SITE HAD AN INFECTION, INFECTION WAS NOTICED ON (B)(6) 2013. PT HAD OPERATIVE INCISION AND DRAINAGE PERFORMED. (DATE NOT REPORTED). START DATE AND TIME OF INFUSION: (B)(6) 2012 AT 13:00 END DATE OF INFUSION: (B)(6) 2013 (TIME NOT REPORTED) IT WAS REPORTED THAT THE CATHETER WAS PLACED STERILE AT THE BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77296 CATHETER CATHETER BSO I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other