BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALIND 23/40 SLOT KIT W/VT

    MDR report key: 3823137 · Received April 30, 2014

    Report

    Report Number
    1317749-2014-00209
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ARGYLE (SHERIDAN)
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE RETURNED CONSISTED OF ONE (1) ASSEMBLED CATHETER 14.5FRX23CM, PALINDROME WITH SLOTS. THE POSSIBLE CAUSES WERE IDENTIFIED. THE LOT NUMBER WAS NOT PROVIDED. THE DHR REVIEW CANNOT BE PERFORMED. MORE INFORMATION WAS REQUESTED TO THE CUSTOMER AND NO ADDITIONAL EVIDENCE WAS PROVIDED FOR THIS ANALYSIS. AFTER VISUAL INSPECTION, A CUT WAS FOUND ON CATHETER BODY. THIS DEFECT HAS BEEN CONFIRMED. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (THIS CUT COULD BE CAUSED DUE TO OVER BENDING, EXCESSIVE FORCE OR SHARP OBJECT). NO ADDITIONAL ACTIONS ARE REQUIRED. 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 NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. PER PROCEDURE, MANUFACTURING PERFORMS 100% LEAK TESTING AT THE FINAL STAGE OF PRODUCTION, WHICH WOULD IDENTIFY THIS ISSUE IN THE CATHETER ASSEMBLY. 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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT DURING A DIALYSIS SESSION, AN IRREPARABLE HOLE WAS FOUND IN THE SILICONE EXTENSION OF THE CATHETER. THE CATHETER WAS PULLED AND REPLACED WITH A NEW CATHETER. NO INFORMATION RELATED TO PATIENT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259542 PALIND 23/40 SLOT KIT W/VT DIALYSIS CATHETER MSD ARGYLE (SHERIDAN) 8888145040 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1