BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR U/ADAPIT STR 1 ARM NOBASE 50/C

    MDR report key: 2853367 · Received November 30, 2012

    Report

    Report Number
    8030673-2012-00246
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INVESTIGATION: ONE SAMPLE WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION OF THE SAMPLE IT WAS NOTED THAT IT WAS DEFORMED AT THE INLET PORT. IN A SIMILAR REPORT THE SAMPLE WAS SUBMITTED TO CHEMICAL ANALYSIS, AND IN ACCORDANCE WITH TEKNOR APEX ANALYSIS IT WAS CONFIRMED THAT THE DEFORMED PORTS WERE EXPOSED TO DEHP. IN CONCLUSION THE DEFORMATION IS CAUSED BY LONG TERM USE WITH THE PVC CONNECTOR. THIS FAILURE REPORTED IS NOT CAUSED BY MANUFACTURING PERSONNEL; THIS TYPE OF DEFECT IS CAUSED DURING LONG-TERM CONTACT OF THE TWO PLASTIC MATERIALS DURING PRODUCT USAGE. A PROJECT HAS BEEN OPENED TO IMPLEMENT A LABELING CHANGE INDICATING THE RISK OF THIS FAILURE WITH LONG TERM CONTACT BETWEEN THESE MATERIALS. A LOT NUMBER WAS NOT PROVIDED; THEREFORE A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE SAMPLE WAS REPORTED TO BE AVAILABLE FOR EVALUATION. UPON COMPLETION OF CAREFUSION'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE, 'THE DRIVER FOUND BLEED IN VALVE INLET PORT MELTED DURING ROUTINE CONCENTRATOR CHECK. IT WAS REPLACED WITH A DIFFERENT BLEED IN VALVE.' CUSTOMER ADDITIONALLY REPORTED THAT THE PORT WAS DEFORMED, BUT NOT FULLY OCCLUDED. THE MELTING WAS FOUND ON ROUTINE CONCENTRATOR CHECKS WHICH ARE PERFORMED EVERY 3 MONTHS. THIS ADAPTER WAS USED WITH A HOME CARE PATIENT THAT NEEDED TO BLEED IN OXYGEN. THE PATIENT USES THE CPAP NIGHTLY. THE ADAPTER IS NOT CLEANED, STERILIZED OR WASHED. IT IS NOT ROUTINELY CHANGED. THE OXYGEN TUBING CONNECTED TO THE ADAPTER IS CHANGED BUT THE ADAPTER IS NOT CHANGED. NO PATIENT INJURY OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNECTOR U/ADAPIT STR 1 ARM NOBASE 50/C CONNECTOR, AIRWAY (EXTENSION) BZA CAREFUSION 004204-A

    Patients

    Seq Age Sex Outcome Treatment
    1