BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONNECTOR WITH MABS/SMA REDUCER WITH LUER LOCK

    MDR report key: 821600 · Received November 5, 2004

    Report

    Report Number
    1718850-2004-00024
    Event Type
    Other
    Date Received
    November 5, 2004
    Date of Event
    September 1, 2004
    Report Date
    November 5, 2004
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE HAD VISIBLE STRESS WHITENING AT THE CRACK SITE ALONG THE LENGTH OF THE LUER PORT. THE STRESS APPEARED TO HAVE BEEN CAUSED BY OVER-TIGHTENING OF THE MATING COMPONENT. TIMING OF THE PORT CRACKING RELATIVE TO THE OVER-TIGHTENING COULD NOT BE ESTABLISHED FROM THE EXAMINATION OF THE PORT NOR THE INFO PROVIDED. THERE WAS NO VISUAL EVIDENCE OF ANY MATERIAL OR MOLDING PROCESS DEFECTS THAT COULD HAVE CONTRIBUTED TO THE ISSUE. COBE SUPPLIES THIS CONNECTOR AS A NON-STERILE COMPONENT TO A DISTRIBUTOR FOR INCORPORATION INTO CUSTOM PERFUSION TUBING SETS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNECTOR WITH MABS/SMA REDUCER WITH LUER LOCK CONNECTOR DWE COBE CARDIOVASCULAR, INC. NA 0317000004

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention