BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PAXGENE® BLOOD DNA TUBE

    MDR report key: 8475603 · Received April 2, 2019

    Report

    Report Number
    9617032-2019-00381
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 21, 2019
    Report Date
    May 7, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    PMA / PMN Number
    K142821
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, THE ISSUE RELATING TO UNDERFILL WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, TESTING OF THE RETAIN SAMPLES WAS CONDUCTED AND UNDERFILL WAS NOT OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TEN BD PAXGENE® BLOOD DNA TUBE DID NOT FILL UP TO 2 ML, RESULTED IN LOWER GDNA YIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS SHOWS THE VOLUME OF FLUID IN THE TUBES ALL USING STANDARD PROCEDURE FOR SAMPLE COLLECTION. THIS IS NOWHERE NEAR 2 ML THAT IT SHOULD BE. OUR PREVIOUS TUBES WERE PERFORMING JUST FINE, BUT OUR PROCESSING LAB CALLED TO ALERT US TO LOW VOLUMES BEING COLLECTED. WHEN WE CHECKED W/ PHLEBOTOMY, THEY HAD NOT CHANGED ANY PROCEDURES FOR COLLECTION. THIS TESTING CONFIRMS IN MY MIND THAT IT IS A DEFECT IN THE TUBES. I SUPPORT THE PAXGENE BLOOD RNA & DNA TUBES AS WELL AS A HANDFUL OF OTHER VACUTAINER TUBES THAT FALL UNDER CELL & BIOMARKER PRESERVATION INCLUDING CPT TUBES. PER YOUR EMAIL YOU REFERENCE CATALOG NUMBER 761165. CAN YOU VERIFY IF IT IS 761165 WHICH IS THE PAXGENE BLOOD DNA TUBE OR 762165 WHICH IS THE PAXGENE BLOOD RNA TUBE? IF SO, PAXGENE BLOOD DNA TUBES SHOULD CONTAIN SUFFICIENT VACUUM TO DRAW 2.0 ML OF BLOOD MAINTAINING THE OPTIMUM BLOOD TO ADDITIVE RATIO. TOWARDS THE END, THE BLOOD COLLECTION SLOWS SOMEWHAT AND THE TUBE SHOULD BE HELD BELOW THE LEVEL OF THE PATIENTS ARM BUT THE TUBE SHOULD NOT BE REMOVED FROM THE HOLDER UNTIL THE BLOOD COMPLETELY STOPS FLOWING. I ALSO WANT TO VERIFY THAT THEY ARE USING A SAFETY LOCK OR PUSH BUTTON BLOOD COLLECTION SET WITH 12 INCH TUBING AND ADAPTOR AS DIRECTED IN THE PRODUCT INSERT. ONE ADDITIONAL REQUIRED STEP IS TO INCLUDE THE PAXGENE TUBES LAST (DNA BEFORE RNA) IN THE DRAW SERIES AS ANOTHER TUBE OR ALTERNATIVELY A ¿PRIMER¿ TUBE SHOULD BE COLLECTED FIRST TO CLEAR THE 200UL OF AIR OR VOID VOLUME FROM THE WING SET TUBING. I WILL NEED TO FILE AN INTERNAL PRODUCT INCIDENT REPORT SO WILL NEED CUSTOMER CONTACT INFORMATION INCLUDING NAME, PHONE NUMBER, INSTITUTION AND DATE OF OCCURRENCE SO THAT OUR COMPLAINTS TEAM CAN FOLLOW UP. IN ADDITION, IF THEY COULD INDICATE THE TOTAL NUMBER OF FAILED TUBES AND APPROXIMATE ACTUAL AMOUNT OF BLOOD DRAWN THAT WOULD BE HELPFUL AS WELL. REPLACEMENT OF THE DEFECTIVE TUBES WILL NOT BE A PROBLEM, PLEASE INDICATE THE ADDRESS WHERE THEY NEED TO BE SENT. REGARDING COMBINING TUBES: SINCE THIS IS A REGULATED MEDICAL DEVICE I CANNOT ENDORSE DEVIATION FROM THE APPROVED PROTOCOL BUT WOULD BE HAPPY TO SPEAK WITH YOUR CUSTOMER ABOUT OPTIONS FOR THE SHORT DRAWN SAMPLES. YIELD AND QUALITY WILL DEPEND ON THE ACTUAL VOLUME OF BLOOD THEY WERE ABLE TO HARVEST. FOR EXAMPLE 1.5 ML WOULD YIELD MORE THAN 0.5 ML DUE NOT ONLY TO TOTAL GDNA AVAILABLE BUT ALSO THE DEVIATION FROM THE IDEAL ADDITIVE:BLOOD RATIO.¿

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TEN BD PAXGENE® BLOOD DNA TUBE DID NOT FILL UP TO 2 ML, RESULTED IN LOWER GDNA YIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS SHOWS THE VOLUME OF FLUID IN THE TUBES ALL USING STANDARD PROCEDURE FOR SAMPLE COLLECTION. THIS IS NOWHERE NEAR 2 ML THAT IT SHOULD BE. OUR PREVIOUS TUBES WERE PERFORMING JUST FINE, BUT OUR PROCESSING LAB CALLED TO ALERT US TO LOW VOLUMES BEING COLLECTED. WHEN WE CHECKED W/ PHLEBOTOMY, THEY HAD NOT CHANGED ANY PROCEDURES FOR COLLECTION. THIS TESTING CONFIRMS IN MY MIND THAT IT IS A DEFECT IN THE TUBES. I SUPPORT THE PAXGENE BLOOD RNA & DNA TUBES AS WELL AS A HANDFUL OF OTHER VACUTAINER TUBES THAT FALL UNDER CELL & BIOMARKER PRESERVATION INCLUDING CPT TUBES. PER YOUR EMAIL YOU REFERENCE CATALOG NUMBER 761165. CAN YOU VERIFY IF IT IS 761165 WHICH IS THE PAXGENE BLOOD DNA TUBE OR 762165 WHICH IS THE PAXGENE BLOOD RNA TUBE? IF SO, PAXGENE BLOOD DNA TUBES SHOULD CONTAIN SUFFICIENT VACUUM TO DRAW 2.0 ML OF BLOOD MAINTAINING THE OPTIMUM BLOOD TO ADDITIVE RATIO. TOWARDS THE END, THE BLOOD COLLECTION SLOWS SOMEWHAT AND THE TUBE SHOULD BE HELD BELOW THE LEVEL OF THE PATIENT¿S ARM BUT THE TUBE SHOULD NOT BE REMOVED FROM THE HOLDER UNTIL THE BLOOD COMPLETELY STOPS FLOWING. I ALSO WANT TO VERIFY THAT THEY ARE USING A SAFETY LOCK OR PUSH BUTTON BLOOD COLLECTION SET WITH 12 INCH TUBING AND ADAPTOR AS DIRECTED IN THE PRODUCT INSERT. ONE ADDITIONAL REQUIRED STEP IS TO INCLUDE THE PAXGENE TUBES LAST (DNA BEFORE RNA) IN THE DRAW SERIES AS ANOTHER TUBE OR ALTERNATIVELY A ¿PRIMER¿ TUBE SHOULD BE COLLECTED FIRST TO CLEAR THE 200UL OF AIR OR VOID VOLUME FROM THE WING SET TUBING. I WILL NEED TO FILE AN INTERNAL PRODUCT INCIDENT REPORT SO WILL NEED CUSTOMER CONTACT INFORMATION INCLUDING NAME, PHONE NUMBER, INSTITUTION AND DATE OF OCCURRENCE SO THAT OUR COMPLAINTS TEAM CAN FOLLOW UP. IN ADDITION, IF THEY COULD INDICATE THE TOTAL NUMBER OF FAILED TUBES AND APPROXIMATE ACTUAL AMOUNT OF BLOOD DRAWN THAT WOULD BE HELPFUL AS WELL. REPLACEMENT OF THE DEFECTIVE TUBES WILL NOT BE A PROBLEM, PLEASE INDICATE THE ADDRESS WHERE THEY NEED TO BE SENT. REGARDING COMBINING TUBES: SINCE THIS IS A REGULATED MEDICAL DEVICE I CANNOT ENDORSE DEVIATION FROM THE APPROVED PROTOCOL BUT WOULD BE HAPPY TO SPEAK WITH YOUR CUSTOMER ABOUT OPTIONS FOR THE SHORT DRAWN SAMPLES. YIELD AND QUALITY WILL DEPEND ON THE ACTUAL VOLUME OF BLOOD THEY WERE ABLE TO HARVEST. FOR EXAMPLE 1.5 ML WOULD YIELD MORE THAN 0.5 ML DUE NOT ONLY TO TOTAL GDNA AVAILABLE BUT ALSO THE DEVIATION FROM THE IDEAL ADDITIVE:BLOOD RATIO.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269698 BD PAXGENE® BLOOD DNA TUBE BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON AND COMPANY (BD) 8164968

    Patients

    Seq Age Sex Outcome Treatment
    1 Other