BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER

    MDR report key: 6563097 · Received May 12, 2017

    Report

    Report Number
    1718850-2017-00008
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    April 10, 2017
    Report Date
    July 6, 2017
    Manufacturer
    SORIN GROUP USA, INC
    Product Code
    DWF
    UDI-DI
    00803622106347
    PMA / PMN Number
    K981601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED VENT CATHETER WAS DISCARDED BY THE CUSTOMER AND COULD NOT BE RETURNED FOR EVALUATION. NO PHOTOGRAPHS OF THE DEVICE WERE TAKEN. THE CUSTOMER PROVIDED TWO LOT NUMBERS BUT WAS NOT SURE WHICH ONE MIGHT HAVE BEEN INVOLVED. RESEARCH WAS UNABLE TO IDENTIFY ANY REMAINING INVENTORY FOR EITHER LOT NUMBER. A PRODUCTION REVIEW FOUND THAT THERE HAVE BEEN OVER 160 BUILDS OF THIS CATALOG NUMBER WITHIN THE PAST YEAR, REPRESENTING ALMOST 80,000 UNITS. THIS IS THE FIRST COMPLAINT FOR THE TWO PARTS OF THE CATHETER SEPARATING. WITHOUT PRODUCT FOR AN IN-DEPTH EVALUATION OF THIS INCIDENT, THE ROOT CAUSE AND APPROPRIATE CORRECTIVE ACTION COULD NOT BE DETERMINED. TO ADDRESS ANY POSSIBLE PRODUCTION ASSEMBLY ISSUES, A MANUFACTURING AWARENESS NOTIFICATION WAS ISSUED TO THE APPROPRIATE WORKFORCE, ALERTING THEM TO THE COMPLAINT AND SENSITIZING THEM TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    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. THE DEVICE WAS SWITCHED OUT TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344748 CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP USA, INC 00803622106347

    Patients

    Seq Age Sex Outcome Treatment
    1