BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BETA CAP ADAPTER

    MDR report key: 3844676 · Received May 15, 2014

    Report

    Report Number
    1317749-2014-00227
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS 314998(JULIAN LOT NUMBER 020439). LOT 314998 WAS RELEASED ON 07/26/10 WITH AN ORDER QUANTITY OF (B)(4) CASES. THE ADAPTER PART NUMBER 12588, LOT NUMBER A36050 WAS UTILIZED IN THE PACKAGING LOT. THE DHR REVIEW INDICATED THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THIS DEFECT MODE.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. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. 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. THIS INFORMATION WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A BETA CAP ADAPTER. THE CUSTOMER STATES THAT THE ADAPTER BARB DAMAGES THE CATHETER WHERE IT MEETS CATHETER AND CAUSES A TEAR, LEAK, AND CONTAMINATION. THE PATIENT REQUIRED ANTIBIOTICS TO PREVENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291506 BETA CAP ADAPTER BETA CAP ADAPTER FJS COVIDIEN 8814661001 020439

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention