BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PC PALINDROME 19/36 KIT WITH SLOT

    MDR report key: 3983565 · Received June 26, 2014

    Report

    Report Number
    1317749-2014-00277
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 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

    THE PRODUCT SAMPLE RETURNED CONSISTED OF ONE PC PALINDROME 19/36 W/SLOT CATHETER. VISUAL INSPECTION WAS PERFORMED AND A CRACK WAS FOUND ON BOTH ADULT ADAPTERS (RED AND BLUE ADAPTERS). THE POSSIBLE CAUSES WERE IDENTIFIED. THE DHR WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NOT NCR RELATED TO THE REPORTED ISSUE. NO CHANGES WERE IDENTIFIED IN THE PROCESS AS RELATED WITH THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. 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 STATED THAT THE ARTERIAL AND VENOUS ENDS IN THE CATHETER JOINT WERE CRACKED. IT WAS FOUND WHEN THE NURSE PREPARED FOR DISINFECTION. THEN THE CATHETER WAS PULLED AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374615 PC PALINDROME 19/36 KIT WITH SLOT DIALYSIS CATHETER MPB COVIDIEN 8888145058 221507X

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR