BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLONG BLOCK BEVEL - 19 GA X 50MM

    MDR report key: 4110262 · Received September 11, 2014

    Report

    Report Number
    2026095-2014-00174
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 14, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    CAZ
    PMA / PMN Number
    K102007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RECEIVED FOR AN ANALYSIS AND A VISUAL INSPECTION HAS BEEN PERFORMED. AT THIS TIME THE DEVICE IS UNDERGOING TESTING. AT THIS TIME A REVIEW OF THE DEVICE HISTORY REVIEW IS IN PROGRESS. RESULTS: EVALUATION AND INVESTIGATION RESULTS WILL BE PROVIDED ONCE THEY ARE COMPLETED. CONCLUSIONS: ONCE THE INVESTIGATION AND DEVICE ANALYSIS ARE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    FILL VOLUME: NOT APPLICABLE, FLOW RATE: NOT APPLICABLE, PROCEDURE: UNK, CATHPLACE: UNK. IT WAS REPORTED ON AN UNKNOWN DATE THAT A NEEDLE HAD BROKE DURING USE. IT WAS REPORTED THAT THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562983 PROLONG BLOCK BEVEL - 19 GA X 50MM ELASTOMERIC PUMP CAZ I-FLOW, LLC PL19100GC 0201188627

    Patients

    Seq Age Sex Outcome Treatment
    1 DRUG: NOT APPLICABLE