BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRAGLIDE COATED 24FR SILICONE CATHETERS

    MDR report key: 1546585 · Received November 19, 2009

    Report

    Report Number
    1219977-2009-00004
    Event Type
    Other
    Date Received
    November 19, 2009
    Date of Event
    October 26, 2009
    Report Date
    November 18, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    GBZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EACH INDIVIDUAL HEPARIN COATED SILICONE CATHETER IS HANDLED 100% AS IT IS STEPPED THROUGH SEVERAL MFG AND INSPECTION PROCESSES PRIOR TO SHIPMENT, SO THE LIKELIHOOD OF THE PRODUCT BEING SHIPPED IN THIS CONDITION IS HIGHLY UNLIKELY. EVIDENCE GATHERED DURING THE VISUAL INSPECTION OF THE RETURNED CATHETER SHOWS WHAT APPEARS TO BE TWO DISTINCT PUNCTURES OPPOSITE EACH OTHER. ADDITIONALLY, RESULTS FROM THE DESTRUCTIVE TESTING PERFORMED ON IDENTICAL CATHETERS SHOWED THAT IF THE WALL OF THE CATHETER IS COMPROMISED, THE INTEGRITY OF THE CATHETER IS WEAKENED. BASED ON THE VISUAL INSPECTION AND THE DESTRUCTIVE TESTING PERFORMED ON IDENTICAL CATHETERS, IT IS OUR CONCLUSION THAT THIS THORACIC CATHETER WAS MANUFACTURED AND PERFORMED TO SPECIFICATION.

    Description of Event or Problem · 1

    PRODUCT IS A HYDRAGLIDE SILICONE CATHETER THAT BROKE OFF AFTER REMOVAL. OPERATING ROOM HAD TO REOPERATE TO REMOVE BROKEN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAGLIDE COATED 24FR SILICONE CATHETERS NONE GBZ ATRIUM MEDICAL CORP. 14724 10535714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention