BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE

    MDR report key: 8884188 · Received August 12, 2019

    Report

    Report Number
    1024879-2019-01402
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 25, 2019
    Report Date
    January 6, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    G. 3 REPORT SOURCE WAS CHANGED FROM "HEALTH PROFESSIONAL" TO "USER FACILITY". H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING MOLDING DEFECTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DURING OUR PRODUCTION ON JULY 25TH, ONE OF OUR TECHNICIANS DISCOVERED BD VACUTAINER SST TM TUBES WITH A DEFECTIVE NECK. INDEED, IT SEEMS THAT THIS IS DUE TO A LACK OF INJECTION. THIS TUBE (REFERENCE 367985) BELONGS TO LOT N° 9003868 WHICH EXPIRES ON (B)(6)2019. THIS DEFECT LEADS TO THE ABSENCE OF VACUUM IN THE TUBE AND THE IMPOSSIBILITY OF TAKING THE DESIRED BLOOD SAMPLE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING MOLDING DEFECTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DURING OUR PRODUCTION ON (B)(6) ONE OF OUR TECHNICIANS DISCOVERED BD VACUTAINER SST TM TUBES WITH A DEFECTIVE NECK. INDEED, IT SEEMS THAT THIS IS DUE TO A LACK OF INJECTION. THIS TUBE (REFERENCE 367985) BELONGS TO LOT N° 9003868 WHICH EXPIRES ON 31 DEC. 2019. THIS DEFECT LEADS TO THE ABSENCE OF VACUUM IN THE TUBE AND THE IMPOSSIBILITY OF TAKING THE DESIRED BLOOD SAMPLE.

    Additional Manufacturer Narrative · 1

    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 MOLDING DEFECTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DURING OUR PRODUCTION ON JULY 25TH, ONE OF OUR TECHNICIANS DISCOVERED BD VACUTAINER SST TM TUBES WITH A DEFECTIVE NECK. INDEED, IT SEEMS THAT THIS IS DUE TO A LACK OF INJECTION. THIS TUBE (REFERENCE (B)(4)) BELONGS TO LOT N° 9003868 WHICH EXPIRES ON 31 DEC. 2019. THIS DEFECT LEADS TO THE ABSENCE OF VACUUM IN THE TUBE AND THE IMPOSSIBILITY OF TAKING THE DESIRED BLOOD SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676013 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9003868 50382903679855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other