BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9145377 · Received October 2, 2019

    Report

    Report Number
    1024879-2019-01738
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 15, 2019
    Report Date
    October 8, 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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION RELATING TO LABEL LIFT THROUGH CAPA #1064141. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE LABEL PARTIALLY PEELED OFF BEFORE USE. CAPA #1064141 WAS OPENED IN RESPONSE TO THIS EVENT, AND THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE CONTINUING TO HAVE ISSUES WITH THE LABELS ON THE 5ML SST TUBES. I OPENED A FLAT ON SUNDAY AND EVERY TUBE ON THE FLAT HAS LABELS THAT ARE NOT FULLY ADHERED (LOT 9081740). I HAVE ALSO NOTICED IT HAS NOW CONTINUED ONTO THE 3.5ML SST TUBE(LOT 9087734)."

    Additional Manufacturer Narrative · 1

    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 LABEL PARTIALLY PEELED OFF BEFORE USE. CAPA (B)(4) WAS OPENED IN RESPONSE TO THIS EVENT, AND THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE CONTINUING TO HAVE ISSUES WITH THE LABELS ON THE 5ML SST TUBES. I OPENED A FLAT ON SUNDAY AND EVERY TUBE ON THE FLAT HAS LABELS THAT ARE NOT FULLY ADHERED (LOT 9081740). I HAVE ALSO NOTICED IT HAS NOW CONTINUED ONTO THE 3.5ML SST TUBE(LOT 9087734)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942620 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9081740 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other