BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8722592 · Received June 21, 2019

    Report

    Report Number
    1024879-2019-01030
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 22, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CORRECT LOT NUMBER WAS RECEIVED BY THE CUSTOMER. THE FOLLOWING INFORMATION HAS BEEN UPDATED: MEDICAL DEVICE LOT#: 9003751 . MEDICAL DEVICE EXPIRATION DATE: 2019-12-31 DEVICE MANUFACTURE DATE: 2019-01-03.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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-CONFORMITIES 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 STOPPER POPPED OUT OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE AFTER USE WHEN IT HAD BEEN PLACED IN A TRANSPORT BAG, AND A REDRAW WAS REQUIRED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ""THE CAPS ARE COMING OFF THE TUBES AFTER THEY WERE PLACED IN A TRANSPORT BAG. OTHER SPECIMENS WERE CONTAMINATED. DATE OF EVENT: (B)(6) 2019 - FEMALE, LOT 9023751"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPER POPPED OUT OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE AFTER USE WHEN IT HAD BEEN PLACED IN A TRANSPORT BAG, AND A REDRAW WAS REQUIRED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ""THE CAPS ARE COMING OFF THE TUBES AFTER THEY WERE PLACED IN A TRANSPORT BAG. OTHER SPECIMENS WERE CONTAMINATED. DATE OF EVENT: ON (B)(6) 2019 - FEMALE, LOT 9023751".

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # [9023751] WAS NOT FOUND FOR THE REPORTED CATALOG # [367986]. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPER POPPED OUT OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE AFTER USE WHEN IT HAD BEEN PLACED IN A TRANSPORT BAG, AND A REDRAW WAS REQUIRED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CAPS ARE COMING OFF THE TUBES AFTER THEY WERE PLACED IN A TRANSPORT BAG. OTHER SPECIMENS WERE CONTAMINATED.DATE OF EVENT: (B)(6) 2019 - FEMALE, LOT 9023751".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518842 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9003751 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other