BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 5382914 · Received January 21, 2016

    Report

    Report Number
    1820334-2016-00015
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    December 22, 2015
    Report Date
    December 29, 2015
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/EVALUATION: DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, DOCUMENTATION, DEVICE HISTORY RECORD, AND A VISUAL INSPECTION AND A FUNCTIONAL TEST OF THE RETURNED USED AND DAMAGED PRODUCT WAS CONDUCTED. ONE SHEATH WAS RETURNED IN A USED CONDITION. THE PRODUCT WAS LIQUID LEAK TESTED BY OCCLUDING THE DISTAL END USING HEMOSTATS. THE BLUE VALVE LEAKED THROUGH THE CENTER OF THE DISC. WITH VERY LITTLE PRESSURE, THE WATER DRIPPED FROM THE CENTER OF THE VALVE. AS PRESSURE WAS INCREASED, THE WATER TENDED TO SQUIRT FROM THE VALVE IN A SMALL STREAM RATHER THAN DRIPPING FROM THE VALVE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO OTHER COMPLAINTS HAVE BEEN RECEIVED INVOLVING LOT 6080977. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    WHEN THE SHEATH WAS INSERTED DURING RADIAL ACCESS, THE VALVE LEAKED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    WHEN THE SHEATH WAS INSERTED DURING RADIAL ACCESS, THE VALVE LEAKED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41677 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1