BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL NERVE BLOCK SUPPORT TRAY

    MDR report key: 4138728 · Received October 1, 2014

    Report

    Report Number
    2026095-2014-00188
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    CAZ
    PMA / PMN Number
    K073187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED TO BE RETURNING FOR ANALYSIS, BUT PENDING RECEIPT. A SAMPLE PHOTOGRAPH WAS PROVIDED FOR A VISUAL VIEW. A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY IN PROGRESS FOR THE LOT NUMBER PROVIDED. RESULTS: RESULTS WILL BE PROVIDED ONCE THE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. CONCLUSIONS: AT THIS TIME THE INVESTIGATION IS STILL IN PROGRESS AND THE DEVICE IS PENDING RECEIPT. ONCE THE DEVICE IS RECEIVED, TESTING WILL BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE. PLEASE NOTE: THE SPIROL CATHETER BELONGS TO A PERIPHERAL NERVE BLOCK TRAY THAT IS ASSEMBLED BY KIMBERLY CLARK, AND THE SUSPECT CATHETER MENTIONED IN THIS INCIDENT IS A COMPONENT OF THE TRAY AND AN EPIMED PRODUCT. FOR THIS CATHETER, THE PRODUCT CODE IS BSO AND THE 510K NUMBER IS K133316.

    Description of Event or Problem · 1

    PROCEDURE: UNK - ANP. CATHPLACE: UNK - ANP. IT WAS REPORTED BY AN I-FLOW PRODUCT REPRESENTATIVE THAT A T-BLOC SPIROL CATHETER SHREDDED WHILE REMOVING THE STYLET. THE DAMAGED CATHETER WAS REMOVED FROM THE PATIENT WITH NO FURTHER PATIENT CONSEQUENCE OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611165 PERIPHERAL NERVE BLOCK SUPPORT TRAY ANESTHESIA CONDUCTIO KIT CAZ I-FLOW, LLC TBT03100ST 0201424935

    Patients

    Seq Age Sex Outcome Treatment
    1 DRUG: N/A