BEUDAMED
    FDA Adverse Event Death Summary report: N

    1917413-2016-00019

    MDR report key: 6201502 · Received December 22, 2016

    Report

    Report Number
    1917413-2016-00019
    Event Type
    Death
    Date Received
    December 22, 2016
    Date of Event
    November 29, 2016
    Report Date
    December 9, 2016
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: SEE MFG REPORT # 1917413-2016-00018 FOR THE MDR FOR THE REPORTED CATALOG 367884 REFERENCED IN THE EVENT DESCRIPTION. MEDICAL DEVICE BRAND NAME: 13 X 75 MM X 4.0 ML BD VACUTAINER PLUS PLASTIC WHOLE BLOOD TUBE. LAVENDER CONVENTIONAL CLOSURE. ADDITIVE: K2EDTA (SPRAY DRIED), 7.2 MG. (B)(4). (B)(6). DEVICE EVALUATION: THE FOLLOWING SAMPLES WERE TESTED FROM THE BD VACUTAINER K2 EDTA TUBE (CATALOG NUMBER 367844, LOT NUMBER 6124782): FORTY SAMPLES OF THE INCIDENT LOT NUMBER WERE RECEIVED FROM BD (B)(4) DISTRIBUTION AND WERE TESTED FOR DRAW VOLUME AT BD (B)(4). WE OBSERVED DRAW VOLUMES THAT RANGED FROM 3.86 ML ¿ 4.05 ML, WHICH IS WITHIN THE SPECIFICATION RANGE FOR THESE TUBES, 3.24 ¿ 4.40 ML. TWENTY SAMPLES FROM THE INCIDENT LOT NUMBER WERE RECEIVED FROM THE CUSTOMER FACILITY IN (B)(6) AND WERE TESTED FOR DRAW VOLUME AT BD (B)(4). WE OBSERVED DRAW VOLUMES THAT RANGED FROM 3.95 ML ¿ 4.04 ML, WHICH IS WITHIN THE SPECIFICATION RANGE FOR THESE TUBES, 3.24 ¿ 4.40 ML. FIVE SAMPLES FROM THE INCIDENT LOT NUMBER WERE RECEIVED FROM BD PAS MANUFACTURING RETENTION INVENTORY (BROKEN BOW, (B)(4)) AND WERE TESTED FOR DRAW VOLUME AT BD (B)(4). WE OBSERVED DRAW VOLUMES THAT RANGED FROM 3.99 ML ¿ 4.05 ML, WHICH IS WITHIN THE SPECIFICATION RANGE FOR THESE TUBES, 3.24 ¿ 4.40 ML. TWENTY SAMPLES FROM THE INCIDENT LOT NUMBER WERE SELECTED FROM BD PAS MANUFACTURING RETENTION INVENTORY (BROKEN BOW, (B)(4)) AND WERE TESTED AT THE SAME LOCATION FOR DRAW VOLUME. WE OBSERVED DRAW VOLUMES THAT RANGED FROM 3.96 ML ¿ 4.08 ML, WHICH IS WITHIN THE SPECIFICATION RANGE FOR THESE TUBES, 3.24 ¿ 4.40 ML. FOR THE ABOVE NOTED TESTING, WE DID NOT OBSERVE TUBE PUSH-OFF FROM THE NEEDLE AND/OR AIR BEING INTRODUCED INTO THE COLLECTION LINE. A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH INCIDENT LOT NUMBER 6124782 WAS PERFORMED, AND WE FOUND NO RELATED QUALITY NOTIFICATIONS ISSUED DURING MANUFACTURING OF THIS LOT. FURTHERMORE, WE HAVE NOT RECEIVED ANY ADDITIONAL CUSTOMER REPORTS OF POSITIVE PRESSURE RELATED INCIDENTS ASSOCIATED WITH THIS LOT. LASTLY, WE CONDUCTED A THOROUGH REVIEW OF THE MANUFACTURING PROCESS FOR THE INCIDENT PRODUCT AND DETERMINED THAT DUE TO THE AUTOMATED EVACUATION SYSTEM THAT WE HAVE IN PLACE WHICH IS CLOSELY MONITORED THERE WERE NO OPPORTUNITIES FOUND WHEREUPON TUBES WITHIN THE EVACUATOR COULD HAVE BEEN POSITIVELY PRESSURIZED. ADDITIONALLY, THERE WERE NO OPPORTUNITIES FOUND WITHIN THE AUTOMATED EVACUATION SYSTEM WHERE A TUBE COULD BE ASSEMBLED WITH A STOPPER WITHOUT THE PRESENCE OF VACUUM. CONCLUSION - BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE RETENTION SAMPLES. ADDITIONALLY, THE CUSTOMER RETURNED ONE BLOOD COLLECTION SET THAT WAS NOT MANUFACTURED BY BD NOR THE ACTUAL ONE USED IN THE COMPLAINT. NO INVESTIGATION WAS PERFORMED ON THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED (B)(6) 2016 FOR CORONARY HEART DISEASE AND MULTIVESSEL DISEASE. HIS HEALTH WAS NOTED TO BE IN POOR CONDITION WHEN ADMITTED. ON (B)(6) 2016 THE PATIENT WAS HAVING HIS BLOOD DRAWN AT THE (B)(6) IN THE DEPARTMENT OF PHYSIOLOGICAL PACING ECG. THE NURSE WAS USING A NON-BD SINGLE WING NEEDLE WITHOUT A HOLDER. THE NURSE PERFORMED THE BLOOD DRAW FROM THE PATIENT¿S RIGHT HAND WITH THE BD VACUTAINER PLUS PLASTIC PLASMA TUBE (CAT 367884) AND "POSITIVE PRESSURE HAPPENED" WITH THE FIRST ATTEMPT, "PUSHING AIR INTO THE PATIENT'S VESSEL", RESULTING IN A "BULGE PHENOMENON" OR BUMP. THE HEAD NURSE THEN PERFORMED A BLOOD DRAW WITH THE BD VACUTAINER PLUS PLASTIC WHOLE BLOOD TUBE (CAT 367844) ON PATIENT¿S LEFT FOOT BUT THE SAME ISSUE WAS OBSERVED. FINALLY THE HEAD NURSE PERFORMED A THIRD BLOOD DRAW TO THE PATIENT'S RIGHT ARM WITH 2 ADDITIONAL TUBES, CAT 367884. THE FIRST TIME TUBE WAS DRAWN WITHOUT ISSUE BUT THE SECOND TUBE WAS ALSO NOTED TO HAVE THE "PROBLEM OF POSITIVE PRESSURE". THE BUMP THAT HAD APPEARED WHERE THE BLOOD DRAW HAD BEEN PERFORMED "DISAPPEARED BY THE HELP OF (THE) NURSE". THE PATIENT WAS REPORTED TO HAVE PASSED AWAY ON THE NIGHT OF (B)(6) 2016 DUE TO HEART FAILURE.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death