BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORACENTESIS TRAY 16G X 3

    MDR report key: 3331795 · Received September 9, 2013

    Report

    Report Number
    1625685-2013-00019
    Event Type
    Death
    Date Received
    September 9, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 9, 2013
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE (1) COMPLAINT SAMPLE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE COMPLAINT SAMPLE CONFIRMED THE REPORTED DEFECT. INSPECTION OF THE CANNULA/HUB JOINT ON THE NEEDLE NOTED THE PRESENCE OF EPOXY ON THE CANNULA, POSSIBLY NOT IN THE PROPER AMOUNT TO SUFFICIENTLY BOND THE HUB TO THE CANNULA, WHICH LED TO THE SEPARATION OF THE CANNULA/HUB JOINT. NO ISSUES WERE FOUND DURING REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INDICATED THAT COULD RESULT IN THE REPORTED CONDITION. THIS INCLUDES REVIEW OF ALL RAW MATERIAL HISTORY FILES AND STERILIZATION BATCH RECORDS. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE FOR THE REPORTED DEFECT WAS DETERMINED TO BE DUE TO NOT APPLYING A SUFFICIENT AMOUNT OF ADHESIVE IN THE CANNULA HUB/CAP JOINT DURING THE MANUFACTURING PROCESS OF THE NEEDLE ASSEMBLY. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES IDENTIFIED SPECIFIC MANUFACTURING STEPS THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE CONTRIBUTION OF THESE MANUFACTURING STEPS WAS EVALUATED DURING AN IN-DEPTH INTERNAL INVESTIGATION AND ACTION PLAN WHICH HAVE BEEN COMPLETED. ALL CORRECTIVE ACTIONS WHICH INCLUDED, BUT WERE NOT LIMITED TO, MANUFACTURING PROCESS CONTROLS AND PERIODIC PREVENTIVE MAINTENANCE HAVE BEEN IMPLEMENTED. IN ADDITION, ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS REPORT IN AN EFFORT TO HEIGHTEN AWARENESS REGARDING THIS ISSUE AND MINIMIZE ANY IMPACT FROM THE MANUFACTURING PROCESSES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE END USER ((B)(6)): PRIOR TO, DURING, AND AFTER THE INCIDENT, THE PT. WAS ON HOSPICE. THE PT. WAS COMING TO THE HOSPITAL WEEKLY FOR DRAINAGES OF 100-600CC OF A PLEURAL EFFUSION. WHEN THE INCIDENT WITH THE NEEDLE OCCURRED ON (B)(6) 2013, THE PT. DEVELOPED A PNEUMOTHORAX WHICH THE PHYSICIAN NOTED TO BE CLINICALLY INSIGNIFICANT AND THAT WOULD JUST BE MONITORED DURING THE WEEKLY VISITS THE PT. MADE TO THE HOSPITAL FOR DRAINAGE SESSIONS. THE PT. THEN CAME INTO THE EMERGENCY ROOM ON (B)(6) 2013. THE PT. WAS NOTED TO HAVE SHORTNESS OF BREATH, THE EXISTING PLEURAL EFFUSION, AND UNDERLYING ATELECTASIS. THE PT. WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013. A CHEST X-RAY TAKEN AT 11:53 AM SHOWED RESIDUAL COLLAPSE OF THE RIGHT LOWER LOBE WITH PNEUMOTHORAX. A CHEST TUBE WAS PLACED TO DRAW FLUID OUT AS THE PT. WAS VERY SHORT OF BREATH. ANOTHER X-RAY TAKEN AT 1:53 PM SHOWED 60% RIGHT LUNG PNEUMOTHORAX, NO CHANGE IN THE PARTIAL COLLAPSE, AND A CONSOLIDATED LUNG. ON (B)(6) 2013, THE PT.¿S FAMILY ELECTED TO HAVE THE CHEST TUBE REMOVED. A LAST X-RAY POST REMOVAL SHOWED A STABLE RIGHT PNEUMOTHORAX AND PERSISTENT INFILTRATE IN THE RIGHT LUNG. THE PT. THEN PASSED AWAY ON (B)(6) 2013. THE END USER CONFIRMED THAT THE PHYSICIAN DID NOT BELIEVE THE INCIDENT WITH THE NEEDLE OR PNEUMOTHORAX HAD ANYTHING TO DO WITH THE PT¿S PASSING, ESPECIALLY AS THE PNEUMOTHORAX WAS NOT SIGNIFICANT. IT WAS REITERATED THAT THE CAUSE OF DEATH WAS THE PT¿S LUNG CANCER.

    Description of Event or Problem · 1

    CARDINAL HEALTH (B)(6) CALLED IN CLAIMING NEEDLE IN ITEM WAS COMING LOOSE, TO THE POINT TO WHERE THE CUSTOMER COULD HEAR AIR COMING OUT. WHEN REMOVING ITEM FROM PATIENT, THE NEEDLE STAYED IN THE PATIENT. ON (B)(6) 2013, CARDINAL HEALTHCARE PROVIDED A COMPLAINT REPORT INDICATING THE CORRECT INCIDENT DATE ((B)(6) 2013) AND THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS A SYRINGE FAILURE DURING THE PROCEDURE. THE 16GA X 3" ASPIRATING NEEDLE CAME LOOSE FROM THE SYRINGE, AIR LEAKAGE WAS HEARD DURING THE PROCEDURE, AND WHEN THE STOPCOCK VALVE WAS LOCKED AND THE SYRINGE WAS REMOVED, THE NEEDLE REMAINED IN THE PATIENT AND RESULTED IN A PNEUMOTHORAX, CHEST DISCOMFORT AND PAIN FOR THE PATIENT. ON (B)(6) 2013, THE END USER (B)(6) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO NOTED DEFECT PRIOR TO EXAM OR ON INSERTION. THIS PATIENT WAS BEING TREATED FOR A PLEURAL EFFUSION. THE DEFECTIVE NEEDLE WAS REMOVED AND A NEW KIT WAS OPENED. POST PROCEDURE, THE PATIENT HAD A POST-OP CHEST X-RAY THAT SHOWED A PNEUMOTHORAX, AND THE PATIENT WAS SENT HOME. THE CURRENT STATUS IS DECEASED. IT WAS A 80 PLUS YEAR OLD FEMALE. THE SAMPLE IS AVAILABLE FOR EVALUATION. THE END USER (B)(6) ALSO INDICATED THAT THE PATIENT WAS DISCHARGED ON THE SAME DATE AS THE INCIDENT AND WAS GOING TO BE FOLLOWED-UP BY CHEST X-RAYS. THE PATIENT PASSED AWAY ON (B)(6) 2013. PER THE PATIENT'S PHYSICIAN, THE OFFICIAL CAUSE OF DEATH WAS NOTED TO BE COMPLICATIONS FROM LUNG CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448469 THORACENTESIS TRAY 16G X 3 NEEDLE, CATHETER GCB CAREFUSION 4340A 0000521503

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention