BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFE-T-CENTESIS TRAY 6FR X 16CM

    MDR report key: 2308842 · Received October 26, 2011

    Report

    Report Number
    1625685-2011-00025
    Event Type
    Injury
    Date Received
    October 26, 2011
    Date of Event
    September 19, 2011
    Report Date
    September 26, 2011
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. CONSEQUENTLY, THE QUALITY OF THE PRODUCT COULD NOT BE EVALUATED IN REGARDS TO THE REPORTED CONDITION. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS FAILURE MODE SINCE A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURE MODES. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE CATHETER/VALVE ASSEMBLY IS SUPPLIED BY AN EXTERNAL VENDOR (CAREFUSION (B)(4) AND IS NOT ALTERED BY THE (B)(6) FACILITY PRIOR TO PLACEMENT IN THE FINISHED GOOD TRAY. A DEVICE HISTORY REVIEW (DHR), RAW MATERIAL HISTORY FILES, AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOTS SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. THIS FAILURE MODE WILL BE ENTERED INTO THE SCAN TRACKING SYSTEM AND APPLICABLE NOTIFICATION WILL BE PROVIDED TO THE VENDOR OF THE CATHETER/VALVE ASSEMBLY (CAREFUSION (B)(4).

    Description of Event or Problem · 1

    ON THIS PATIENT, FLUID LEAKED OUT OF THE CATHETER AND EVERY TIME THE PATIENT TOOK A BREATH, AIR WAS PULLED INTO THE CHEST.  THE PATIENT DEVELOPED A "SIGNIFICANT PNEUMOTHORAX, WHICH DID RESOLVE".   SAMPLE NOT AVAILABLE. ON (B)(6) 2011, THE RADIOLOGIST INVOLVED CLARIFIED THAT DURING THE THORACENTESIS, THE VALVE WAS LEAKING CAUSING A 20% PNEUMOTHORAX WHICH WAS NOT CLINICALLY SIGNIFICANT. THE PNEUMOTHORAX DID NOT REQUIRE PLACEMENT OF AN ADDITIONAL CHEST TUBE. THEY JUST HAD TO STOP THE DRAINAGE SESSION AND LET IT RESOLVE ON ITS OWN. THE RADIOLOGIST INDICATED THERE WERE NO FURTHER PROBLEMS AND THIS WENT UNNOTICED BY THE PATIENT.  ON (B)(6) 2011, THE LAB MANAGER ((B)(6)) INDICATED THAT THE RADIOLOGIST HAD NOT PUNCTURED THE VALVE MORE THAN ONCE AS HE IS AN EXPERIENCED, SKILLED, USER OF THIS PRODUCT. THE LAB MANAGER ALSO INDICATED THAT AN UNUSED SAMPLE FROM THE SAME LOT IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-T-CENTESIS TRAY 6FR X 16CM NEEDLE, CATHETER GCB CAREFUSION PIG1260T 0000341522

    Patients

    Seq Age Sex Outcome Treatment
    1 Other