BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-Z COIL SPECIAL (OZ C CA2)

    MDR report key: 5439165 · Received February 16, 2016

    Report

    Report Number
    3009211636-2016-00082
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 15, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 02/16/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. THE DEVICE HISTORY RECORD (DHR) REVIEW INDICATED THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THIS FAILURE. ALL DHR ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. SINCE THE SAMPLE WAS NOT RETURNED, THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHAT COULD CAUSE THIS EVENT. SHOULD THE SAMPLE BE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, (B)(4) IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS ON (B)(6) 2016, A LEAK WAS OBSERVED IN THE AREA OF THE PROXIMAL FELT-COUPLING ON THE OREOPOULOS-ZELLERMAN CURL CATHETER DURING THE OPERATION. THE WOUNDS ARE INTRACUTANEOUSLY STITCHED. THE PATIENT IS A RENAL HOMECARE PATIENT. THERE WAS PATIENT INVOLVEMENT; BUT NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95581 O-Z COIL SPECIAL (OZ C CA2) DIALYSIS CATHETER FJS COVIDIEN 8888425710 308726X

    Patients

    Seq Age Sex Outcome Treatment
    1