BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8616481 · Received May 16, 2019

    Report

    Report Number
    1024879-2019-00879
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 27, 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

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, 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 THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS ORIGINALLY ONE LOT 9010922 THAT WAS THE ISSUE. HOWEVER NOW, HERE IN OUR PRACTICE WE ARE CONTINUING TO SEE ISSUES WITH LOT 9029641. THE ONLY COMMONALITY THESE PACKS HAVE IN COMMON IS THE EXPIRATION DATE OF 31JAN2020. EXTRA SST¿S DRAWN TO EQUAL NEEDED AMOUNT ORIGINALLY USED FOR LESS SST¿S

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS ORIGINALLY ONE LOT 9010922 THAT WAS THE ISSUE. HOWEVER NOW, HERE IN OUR PRACTICE WE ARE CONTINUING TO SEE ISSUES WITH LOT 9029641. THE ONLY COMMONALITY THIS PACKS HAVE IN COMMON IS THE EXPIRATION DATE OF 31JAN2020. EXTRA SST¿S DRAWN TO EQUAL NEEDED AMOUNT ORIGINALLY USED FOR LESS SST¿S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407801 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9029641 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other