BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8596534 · Received May 9, 2019

    Report

    Report Number
    1024879-2019-00860
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 24, 2019
    Report Date
    June 18, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES UNDERFILL. THIS OCCURRED IN 400 SEPARATE OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367988, BATCH NO. 9010922. THE CUSTOMER HAD WITNESSED UNDER -FILLING IN ALL OF THESE TUBES. PHONE CALL RECEIVED, - WE HAVE BEEN EXPERIENCING UNDER FILLING OF EACH OF THESE TUBES. I WOULD SAY ABOUT 400 TUBES BUT I COULDN'T TELL YOU A SPECIFIC DATE FOR ALL THESE TUBES. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR DRAW VOLUME WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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. BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR DRAW VOLUME WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. 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 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES UNDERFILL. THIS OCCURRED IN 400 SEPARATE OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367988, BATCH NO. 9010922. THE CUSTOMER HAD WITNESSED UNDER FILLING IN ALL OF THESE TUBES. PHONE CALL RCVD, WE HAVE BEEN EXPERIENCING UNDER FILLING OF EACH OF THESE TUBES. I WOULD SAY ABOUT 400 TUBES BUT I COULDN'T TELL YOU A SPECIFIC DATE FOR ALL THESE TUBES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES UNDERFILL. THIS OCCURRED IN 400 SEPARATE OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367988, BATCH NO. 9010922. THE CUSTOMER HAD WITNESSED UNDER FILLING IN ALL OF THESE TUBES. PHONE CALL RCVD, - "(B)(6) AND WE HAVE BEEN EXPERIENCING UNDER FILLING OF EACH OF THESE TUBES. I WOULD SAY ABOUT 400 TUBES BUT I COULDN'T TELL YOU A SPECIFIC DATE FOR ALL THESE TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387574 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9010922 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other