BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER SHEATHS

    MDR report key: 2783606 · Received October 4, 2012

    Report

    Report Number
    2026095-2012-00245
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 7, 2012
    Manufacturer
    I-FLOW CORP.
    Product Code
    DYB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE WILL BE RETURNED FOR EVAL AND INVESTIGATION. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: IF ADDITIONAL INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: UNK. FLOW RATE: 2ML/HR. PROCEDURE: POSTERIOR CERVICAL FUSION. CATHPLACE: BACK. PLEASE REFERENCE: (2026095-2012-00243/12-00959 A). SHEATH B: DOCTOR PLACED CATHETER SHEATHS WITHOUT CATHETERS AS HE WAS OPERATING. HE PLACED TWO SHEATHS ORIGINALLY. WENT TO PLACE THE FIRST CATHETER AND THE 1ST SHEATH BROKE. DOCTOR MADE A SECONDARY INCISION TO RETRIEVE PIECE BUT WAS UNABLE TO FIND IT. DOCTOR THEN WENT TO PLACE SECOND CATHETER AND THE SECOND SHEATH BROKE AS WELL. DOCTOR REMOVED BOTH THE SHEATH AND CATHETER. DOCTOR THEN PLACED A THIRD SHEATH AND INSERTED THE CATHETER WITHOUT IT BREAKING. HE THEN REMOVED THE THIRD SHEATH. DATE OF SURGERY: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER SHEATHS CATHETER SHEATHS DYB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other