BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM ADAPTER

    MDR report key: 4133282 · Received October 1, 2014

    Report

    Report Number
    3009211636-2014-00107
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 9, 2014
    Manufacturer
    COSTA RICA
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/01/2014.AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    PLEASE SEE SECTION FOR INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE PRODUCT SAMPLE WAS NOT RETURNED AND NO PHOTOS WERE RECEIVED. MORE INFORMATION WAS REQUESTED TO THE CUSTOMER AND NO ADDITIONAL EVIDENCE WAS PROVIDED FOR THIS ANALYSIS. THIS COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY IF THE PRODUCT SAMPLE IS RETURNED. ALL THE POSSIBLE CAUSES WERE IDENTIFIED. THE DHR WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NOT NCRS RELATED TO THE REPORTED ISSUE. THIS DEFECT HAS NOT BEEN CONFIRMED. THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITH THE AVAILABLE INFORMATION AND BASED ON THE ISHIKAWA DIAGRAM (REFER TO INVESTIGATION), SINCE THIS IS AN ACCESSORY THAT IS INSTALLED BY THE CUSTOMER, THE MOST PROBABLE ROOT CAUSE COULD BE ATTRIBUTED TO AN USER S IMPROPER INSTALLATION WHICH CAUSES ADAPTER S DETACHING. HOWEVER WITHOUT THE SAMPLE, THIS CANNOT BE CONFIRMED. NO ADDITIONAL ACTIONS ARE REQUIRED. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE FACILITIES. 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 TITANIUM ADAPTER. THE CUSTOMER STATES THAT DURING USE, THE TITANIUM ADAPTOR DETACHED FROM THE TERUMO TRANSFER TUBE SET. SUBSEQUENTLY, ON (B)(6) 2014, THE CUSTOMER PROVIDED NEW INFORMATION THAT INDICATED THE PATIENT CONTRACTED A PERITONITIS INFECTION. IT IS UNKNOWN IF THE ADAPTER DETACHMENT WAS THE CAUSE OF THE INFECTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611674 TITANIUM ADAPTER TITANIUM ADAPTER KDJ COSTA RICA 8888422378 135440

    Patients

    Seq Age Sex Outcome Treatment
    1