BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/ SLOT

    MDR report key: 3983568 · Received June 26, 2014

    Report

    Report Number
    1317749-2014-00279
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE RETURNED WAS A 14.5 FR PALINDROME CATHETER. THE POSSIBLE CAUSES WERE IDENTIFIED. THE DHR WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NO NCR RELATED TO THE REPORTED ISSUE. NO CHANGES WERE IDENTIFIED IN THE PROCESS AS RELATED WITH THIS EVENT. THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS 355726. DURING VISUAL INSPECTION, IT WAS NOTICED THAT THE VENOUS ADAPTER WAS CRACKED ON THE THREAD AREA. THIS DEFECT HAS BEEN CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE CAN BE CONSIDERED AS MISUSE (ADAPTER COULD BE CRACKED DUE TO OVER TIGHTENING). NO ADDITIONAL ACTION IS 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% VISUAL INSPECTION FOR CRACKED ADAPTERS 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.

    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 CRACKS SHOWED ON THE ADAPTERS LEADING TO BLOOD LEAKAGE. THE CATHETER WAS PULLED OUT AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374616 PALINDROME 19/36 KIT W/ SLOT DIALYSIS CATHETER MPB COVIDIEN 8888145014 301022X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK