BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING CONNECTOR BULKHEAD ADAPTER

    MDR report key: 3038016 · Received April 1, 2013

    Report

    Report Number
    1213649-2013-00018
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    CADENCE INC.
    Product Code
    DTL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CADENCE ACKNOWLEDGES THIS REPORT DOES NOT MEET THE THIRTY DAY REPORTING REQUIREMENT. THIS WAS UNINTENTIONAL. THIS REPORT IS BEING FILED AFTER IT WAS IDENTIFIED AS NON-COMPLIANT DURING INTERNAL REVIEW OF OUR COMPLAINT FILES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE ADAPTER DID NOT HAVE A THROUGH-HOLE AND IS NOT USABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132343 TUBING CONNECTOR BULKHEAD ADAPTER ADAPTER DTL CADENCE INC. 6453 W002568-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other