BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR U/ADAPIT STR NO BASE 50/CS

    MDR report key: 3995806 · Received August 8, 2014

    Report

    Report Number
    8030673-2014-00119
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 11, 2014
    Manufacturer
    CAREFUSION
    Product Code
    BZA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: ON (B)(6) 2014, THE MANUFACTURING PLANT RECEIVED A SAMPLE RETURNED FOR EVALUATION. THE SAMPLE WAS SUBMITTED TO IR SCAN AND IT WAS CONCLUDED THAT THE PORTS WERE EXPOSED TO DEHP. THEREFORE, THE DEFORMATION CONCLUDED TO BE BY LONG TERM USE WITH PVC CONNECTOR ON THE PORTS OF THE ADAPTER.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO SAMPLE WAS RETURNED FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. DUE TO SIMILAR REPORTS REPORTED, IT WAS CONCLUDED THAT THE PORTS FROM THE ADAPTER OF PRODUCT 004078 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 DEVICE HISTORY RECORD REVIEW FOR THE LOT REPORTED THAT COULD RESULT IN THE REPORTED CONDITION. AT THIS TIME THERE IS NO EVIDENCE THAT CONFIRMS THAT CAREFUSION OPERATIVE PERSONNEL IS 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 004078 ADAPTER SHOULD BE CHANGED EVERY 30 DAYS. CAREFUSION WILL CONTINUE TO MONITOR AND TREND THIS REPORT.

    Description of Event or Problem · 1

    SALES REP REPORTED VIA TELEPHONE TO AIRLIFE SALES SUPPORT:CUSTOMER COMPLAINT THAT THE HEATER THEY ARE USING IS MELTING THE PORT.   ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE ON (B)(6) 2014:WRITER CALLED CUSTOMER ((B)(6)) BUT STAFF STATED HE IS OUT OF THE OFFICE TILL MONDAY. WRITER SPOKE TO RT ((B)(6)) WHO STATED THAT SHE WAS AWARE OF THE ISSUE. SHE STATED THE PRODUCT IS USED FOR CPAP/BIPAP OXYGEN BLEED IN WHICH HAS HEATED HUMIDIFICATION. WHEN ASKED HOW OFTEN THE PRODUCT IS CHANGED, SHE STATED AS NEEDED. THE MELTING CONDITIONS WERE OBSERVED BY PATIENT SERVICE TECHNICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471567 CONNECTOR U/ADAPIT STR NO BASE 50/CS CONNECTOR, AIRWAY (EXTENSION) BZA CAREFUSION 004078-A 0000637524

    Patients

    Seq Age Sex Outcome Treatment
    1