BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    MDR report key: 10296000 · Received July 20, 2020

    Report

    Report Number
    1024879-2020-00483
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 24, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678209
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. A REVIEW OF SPECIMEN HANDLING PARAMETERS SHOULD BE REVIEWED FOR THIS TUBE TYPE. TECHNICAL SERVICE FOLLOWED UP WITH CUSTOMER AND PROVIDED TRANSPORT AND COLLECTION SUGGESTIONS. THIS COMPLAINT CANNOT BE CONFIRMED BASED ON THE INVESTIGATION CONDUCTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBE SAMPLE WOULD NOT COAGULATE DURING USE WITHIN "1 TO 2 HOURS", AND TOOK "4 TO 5 HOURS" TO CLOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER IS STATING THAT THE SAMPLES ARE NOT COAGULATING WITHIN THE 1 TO 2 HOURS. THE INCIDENT OCCURRED ON (B)(6) 2020; OCCURRENCE: 1; SAMPLES ARE NOT AVAILABLE; THE CUSTOMER WANTS TO KNOW WHY IT'S TAKING 4 TO 5 HOURS TO COAGULATE" "CUSTOMER HAD AN ISSUE WITH THE TUBE TAKING SO LONG TO CLOT FOR REF# (B)(4). HE INDICATED THAT IT WAS TAKING ABOUT 4-5 HOURS FOR THE TUBE TO COMPLETELY CLOT. AFTER SPEAKING WITH HIM, HE INDICATED THAT THE SPECIMEN WAS DRAWN BY A NURSE IN THE PATIENT'S HOME. I THEN ASKED ABOUT PRE-COLLECTION STORAGE CONDITIONS, IN BOTH THE HOSPITAL AND IN THE NURSE'S CAR. THE TUBES ARE KEPT AT RT IN THE LAB PRIOR TO BEING USED, HOWEVER, HE WAS NOT SURE HOW THE NURSES WERE STORING OR TRANSPORTING THE TUBES IN THE VEHICLES. I ALSO ASKED HOW THE TUBE WAS COLLECTED IN THE PATIENT HOME AND IF THE TUBE WAS MIXED 8-10 TIMES. AGAIN, HE WAS NOT AWARE OF THE PROCESS USED BY THE NURSES IN THE HOMES. I SUGGESTED THAT HE INFORM THE NURSES TO TRANSPORT THE TUBE IN A CONTAINER (INSULTED COOLER, ETC.) TO PROTECT THEM FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT BOTH PRIOR TO COLLECTION AND AFTER COLLECTION. I ALSO INDICATED THAT THEY MIGHT WANT TO HAVE TUBE RACKS SO THAT THE TUBES CAN BE TRANSPORTED IN AN UPRIGHT POSITION TO FACILITY PROPER HANDLING AND TRANSPORT BACK TO THE LAB (CEW (B)(6) 2020). I CALLED THE CUSTOMER BACK TO ASK IF THE SPECIMEN BEING DRAWN WAS FOR CLINICAL LABORATORY WORK OR FOR RESEARCH LAB AND HE INDICATED RESEARCH. I ASKED IF IT WERE POSSIBLE THAT THE PATIENT MIGHT BE ON ANTICOAGULANT THERAPY OR HAVE ANY UNDERLYING HEALTH ISSUES THAT WOULD INTERFERE WITH THE CLOTTING OF THE BLOOD, HE INDICATED THAT ALL THE STUDY SUBJECTS WERE HEALTHY VOLUNTEERS (CEW (B)(6) 2020)."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. FDA DEVICE PROBLEM CODE: (B)(4), FDA PATIENT PROBLEM CODE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBE SAMPLE WOULD NOT COAGULATE DURING USE WITHIN "1 TO 2 HOURS", AND TOOK "4 TO 5 HOURS" TO CLOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER IS STATING THAT THE SAMPLES ARE NOT COAGULATING WITHIN THE 1 TO 2 HOURS. THE INCIDENT OCCURRED ON (B)(6) 2020 OCCURRENCE: 1 SAMPLES ARE NOT AVAILABLE THE CUSTOMER WANTS TO KNOW WHY IT'S TAKING 4 TO 5 HOURS TO COAGULATE" "CUSTOMER HAD AN ISSUE WITH THE TUBE TAKING SO LONG TO CLOT FOR REF# 367820. HE INDICATED THAT IT WAS TAKING ABOUT 4-5 HOURS FOR THE TUBE TO COMPLETELY CLOT. AFTER SPEAKING WITH HIM, HE INDICATED THAT THE SPECIMEN WAS DRAWN BY A NURSE IN THE PATIENT'S HOME. I THEN ASKED ABOUT PRE-COLLECTION STORAGE CONDITIONS, IN BOTH THE HOSPITAL AND IN THE NURSE'S CAR. THE TUBES ARE KEPT AT RT IN THE LAB PRIOR TO BEING USED, HOWEVER, HE WAS NOT SURE HOW THE NURSES WERE STORING OR TRANSPORTING THE TUBES IN THE VEHICLES. I ALSO ASKED HOW THE TUBE WAS COLLECTED IN THE PATIENT HOME AND IF THE TUBE WAS MIXED 8-10 TIMES. AGAIN, HE WAS NOT AWARE OF THE PROCESS USED BY THE NURSES IN THE HOMES. I SUGGESTED THAT HE INFORM THE NURSES TO TRANSPORT THE TUBE IN A CONTAINER (INSULTED COOLER, ETC.) TO PROTECT THEM FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT BOTH PRIOR TO COLLECTION AND AFTER COLLECTION. I ALSO INDICATED THAT THEY MIGHT WANT TO HAVE TUBE RACKS SO THAT THE TUBES CAN BE TRANSPORTED IN AN UPRIGHT POSITION TO FACILITY PROPER HANDLING AND TRANSPORT BACK TO THE LAB (CEW 29-JUN-2020). I CALLED THE CUSTOMER BACK TO ASK IF THE SPECIMEN BEING DRAWN WAS FOR CLINICAL LABORATORY WORK OR FOR RESEARCH LAB AND HE INDICATED RESEARCH. I ASKED IF IT WERE POSSIBLE THAT THE PATIENT MIGHT BE ON ANTICOAGULANT THERAPY OR HAVE ANY UNDERLYING HEALTH ISSUES THAT WOULD INTERFERE WITH THE CLOTTING OF THE BLOOD, HE INDICATED THAT ALL THE STUDY SUBJECTS WERE HEALTHY VOLUNTEERS (CEW 29-JUN-2020)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757952 BD VACUTAINER SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367820 UNKNOWN 50382903678209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other