BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL CATH C CA2

    MDR report key: 4652320 · Received April 2, 2015

    Report

    Report Number
    3009211636-2015-00188
    Event Type
    Injury
    Date Received
    April 2, 2015
    Date of Event
    December 6, 2014
    Report Date
    March 19, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS NOT PROVIDED. WITHOUT THE LOT NUMBER, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITHOUT THE SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A CONFIRMED ROOT CAUSE OF THIS ISSUE. SHOULD THE SAMPLE BE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. A CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NON-CONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATED IN (B)(6), A SPONTANEOUS CASE WAS REPORTED TO (B)(4) BY FAX ON (B)(6) 2015 FROM (B)(6). THE COMPLAINT REFERS TO AN ADAPTER (CODE UNKNOWN LOT UNKNOWN). THE REPORTER STATES THAT A PATIENT EXPERIENCED A LEAK FOLLOWING A DISCONNECTION OF THE MINISET (LOT UNKNOWN) AND THE ADAPTOR FROM THE KIT CODE 8888411702. THE DRESSING WAS WET. THE PATIENT CATHETER AND THE ADAPTOR WERE PLACED ON (B)(6) 2014. THE TRANSFER LINE WAS ALWAYS UNDER A DRESSING, NO MANIPULATION OF THE PATIENT. THE PATIENT HAD TO HAVE A ANTIBIOPROPHYLAXIS TREATMENT. THE OCCURRENCE DATE IS (B)(6) 2014. THIS ISSUE OCCURRED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216620 COIL CATH C CA2 DIALYSIS CATHETER MSD COVIDIEN 8888411702 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening