BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING HEMOSTATIC VALVE

    MDR report key: 2990138 · Received March 5, 2013

    Report

    Report Number
    2024168-2013-01276
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    December 15, 2012
    Report Date
    February 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DYB
    PMA / PMN Number
    K934624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED DATE OF EVENT. (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED LOOSE CONNECTION AND LEAK WERE NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE STATES: THE ROTATING HEMOSTATIC VALVE SHOULD NOT UNDERGO PRESSURE GREATER THAN (B)(4) PSI. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETIME ON AN UNSPECIFIED DAY IN (B)(6) 2012, WHILE PERFORMING AN INJECTION PROCEDURE AT 1000 PSI, THE OPEN END OF THE ROTATING HEMOSTATIC VALVE (RHV) DID NOT CONNECT PROPERLY TO THE STOPCOCK. DUE TO THE POOR CONNECTION, LEAKING OCCURRED DUE TO THE IMPROPER SEAL. THERE WAS NO FORCE APPLIED TO THE Y-CONNECTOR. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ABBOTT RETURN GOODS PRELIMINARY ANALYSIS FOUND THAT THE RHV ROTATOR WAS SEPARATED. ADDITIONAL REPORTED INFORMATION INDICATES THAT THE ROTATOR SEPARATION OCCURRED AFTER THE PROCEDURE DUE TO CATH LAB STAFF HANDLING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94362 ROTATING HEMOSTATIC VALVE ACCESSORIES DYB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDRAD POWER INJECTOR