BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE

    MDR report key: 9401890 · Received December 3, 2019

    Report

    Report Number
    1024879-2019-02067
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 18, 2019
    Report Date
    January 31, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679855
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED. TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND UNDERFILL WAS 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA 470822 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND IMPLEMENTED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING UNDERFILL DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: -IT IS REPORTED CUSTOMER EXPERIENCED UNDER-FILLING WHEN USING VACUTAINERS. EMAIL VERBIAGE RECEIVED, - "WE HAVE HAD SOME ISSUES WITH OUR BD VACUTAINER TUBES POSSIBLY LOSING SOME OF THE VACUUM. OUR PHLEBOTOMIST HAS HAD ISSUES GETTING THE TUBES TO FILL WITH BLOOD. I¿M JUST WONDERING IF THERE IS A KNOWN ISSUE WITH THE LOT THAT WE RECEIVED. ITEM 02-683-98 BD VACUTAINER¿ VENOUS BLOOD COLLECTION TUBES: SST¿ SERUM SEPARATION TUBES: CONVENTIONAL STOPPER (10 ML) LOT 9003868-2019-12-31." SHE IS NOT THE PHLEBOTOMIST, BUT THEY HAVE COMPLAINED TO HER THAT THEY HAVE HAD 2-3 TIMES WHERE THE TUBE ONLY FILLED ABOUT 1/2 WAY. THEY ARE USING A WING SET BUT SHE DID NOT KNOW IF IT WAS A BD SET. DISCUSSED THAT TUBES SHOULD BE HELD TIGHTLY IN THE HOLDER AND ALLOW THE VACUUM TO BE EXHAUSTED BEFORE WITHDRAWING TUBE. THEY ARE USING A 23 G NEEDLE SO ALSO SUGGESTED TO CHECK TOURNIQUEST TIME AS THIS IS A LARGE VOLUME TUBE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING UNDERFILL DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED UNDER-FILLING WHEN USING VACUTAINERS. EMAIL VERBIAGE RECEIVED, "WE HAVE HAD SOME ISSUES WITH OUR BD VACUTAINER TUBES POSSIBLY LOSING SOME OF THE VACUUM. OUR PHLEBOTOMIST HAS HAD ISSUES GETTING THE TUBES TO FILL WITH BLOOD. I¿M JUST WONDERING IF THERE IS A KNOWN ISSUE WITH THE LOT THAT WE RECEIVED. ITEM 02-683-98 BD VACUTAINER¿ VENOUS BLOOD COLLECTION TUBES: SST¿ SERUM SEPARATION TUBES: CONVENTIONAL STOPPER (10 ML) LOT 9003868-2019-12-31." SHE IS NOT THE PHLEBOTOMIST, BUT THEY HAVE COMPLAINED TO HER THAT THEY HAVE HAD 2-3 TIMES WHERE THE TUBE ONLY FILLED ABOUT 1/2 WAY. THEY ARE USING A WING SET BUT SHE DID NOT KNOW IF IT WAS A BD SET. DISCUSSED THAT TUBES SHOULD BE HELD TIGHTLY IN THE HOLDER AND ALLOW THE VACUUM TO BE EXHAUSTED BEFORE WITHDRAWING TUBE. THEY ARE USING A 23 G NEEDLE SO ALSO SUGGESTED TO CHECK TOURNIQUEST TIME AS THIS IS A LARGE VOLUME TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201615 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367985 9003868 50382903679855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other