BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD

    MDR report key: 4215530 · Received October 30, 2014

    Report

    Report Number
    8030673-2014-00131
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 30, 2014
    Report Date
    December 19, 2016
    Manufacturer
    CAREFUSION
    Product Code
    BZA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF MDR SUBMISSIONS. CORRECTIONS AND ADDITIONAL INFORMATION HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION:ONE SAMPLE AND PICTURE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS SUBMITTED TO IR SCAN AND IT WAS CONCLUDED THAT THE PORTS FROM THE ADAPTER OF PRODUCT 004081 WERE EXPOSED TO DEHP. PVC MAY CAUSE THE OXYGEN PORT TO DISCOLOR OR DEFORM. IN CONCLUSION, THE DEFORMATION COULD BE CAUSED BY LONG TERM USE WITH PVC CONNECTOR ON THE PORTS OF THE ADAPTER. NO ISSUES WERE FOUND DURING THE REVIEW OF INTERNAL PRODUCTION RECORDS FOR THE LOT INDICATED THAT COULD RESULT IN THE REPORTED CONDITION. AT THIS TIME THERE IS NO EVIDENCE THAT CONFIRMS THAT CAREFUSION OPERATIVE PERSONNEL ARE CONTRIBUTING TO THIS CONDITION. INTERNAL PROCEDURE CALLS FOR A VISUAL INSPECTION OF THIS PRODUCT PRIOR TO PASSING TO THE NEXT STAGE. IN ADDITION, NO ISSUES WERE FOUND WITH THE MATERIALS OR DESIGN OF THIS PRODUCT; THE MATERIALS USED FOR THIS CATALOG ARE VALIDATED. BASED ON THE INVESTIGATION, THE MOST PROBABLE CAUSE FOR THE ISSUE REPORTED COULD BE RELATED TO THE LONG TERM USE WITH PVC CONNECTOR - PLASTICIZERS AS DEHP IN FLEXIBLE PVC MAY CAUSE THE OXYGEN PORT TO DISCOLOR OR DEFORM. AS AN ACTION PLAN, A MODIFICATION WILL BE IMPLEMENTED ON THE INSTRUCTIONS FOR USE OF THIS PRODUCT TO INCLUDE THE STATEMENT, "UP TO 30 DAYS" AND "CAUTION: DEVICES DESIGNED TO BE ATTACHED TO THIS ADAPTER MAY CONTAIN FLEXIBLE PVC. PLASTICIZERS IN FLEXIBLE PVC MAY CAUSE THE OXYGEN PORT TO DISCOLOR OR DEFORM. PERIODICALLY INSPECT THE CONNECTION AND REPLACE PRODUCT IF DAMAGE OR WEAR IS OBSERVED¿. THE 004081 ADAPTER SHOULD BE CHANGED EVERY 30 DAYS. CAREFUSION WILL CONTINUE TO MONITOR AND TREND THIS REPORT.

    Description of Event or Problem · 1

    OXYGEN PORT MELTED WHILE BEING USED IN-LINE FOR CPAP. SITUATION: 2-1/2¿ TUBE COMING OFF OF HUMIDIFIER AND THEN THE 004081 IS CONNECTED TO THAT AND THEN THE CPAP TUBE IS ON THE OTHER END. PATIENTS SAID THE OXYGEN TUBING WAS LOOSE ON THE OXYGEN PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696449 CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD CONNECTOR, AIRWAY (EXTENSION) BZA CAREFUSION 004081-A 0000588117

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention