BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER

    MDR report key: 6556902 · Received May 10, 2017

    Report

    Report Number
    1718850-2017-00007
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Report Date
    July 10, 2017
    Manufacturer
    SORIN GROUP USA, INC
    Product Code
    DWF
    UDI-DI
    00803622106439
    PMA / PMN Number
    K981601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PHOTOGRAPH OF AN UNUSED MALLEABLE VENT CATHETER WAS PROVIDED BY THE CUSTOMER, SHOWING THE AREA OF DISCONNECTION TO BE AT THE CATHETER TO VENT CONNECTION JUNCTION. RESEARCH INTO THE REPORTED LOT NUMBER FOUND THAT THERE WAS NO REMAINING INVENTORY AVAILABLE FOR FURTHER INVESTIGATION. THERE HAVE BEEN OVER 110 BUILDS OF THIS CATALOG NUMBER WITHIN THE PAST YEAR, REPRESENTING ALMOST 20,000 UNITS. THIS IS THE FIRST REPORT AGAINST THIS CATALOG NUMBER FOR ANY REASON, INCLUDING DISCONNECTION. WITHOUT THE ABILITY TO CONDUCT AN IN-DEPTH EVALUATION OF THE PRODUCT, A ROOT CAUSE COULD NOT BE DETERMINED. TO ADDRESS ANY POSSIBLE PRODUCTION ASSEMBLY ISSUES, A MANUFACTURING AWARENESS NOTIFICATION WAS ISSUED TO THE APPROPRIATE WORKFORCE, ALERTING AND SENSITIZING THE WORKFORCE TO THE REPORTED MALFUNCTION. PHOTO RECEIVED; ACTUAL DEVICE DISCARDED.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, SORIN GROUP LEARNED THAT THE DEVICE HAS BEEN DISCARDED BY THE CUSTOMER. IT WAS ALSO REPORTED THAT THERE WAS NO DELAY IN THE SURGERY. THE INVESTIGATION IS ON-GOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TIP OF THE MALLEABLE VENT CATHETER DISCONNECTED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340232 CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP USA, INC 1633600160 00803622106439

    Patients

    Seq Age Sex Outcome Treatment
    1