BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8926617 · Received August 23, 2019

    Report

    Report Number
    1024879-2019-01509
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 5, 2019
    Report Date
    October 7, 2019
    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
    NJ, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED AN AIR BUBBLE WITHIN A TUBE OR GAS SYRINGE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367985, BATCH NO. 9172620 AND 9172620. IT WAS REPORTED AIR BUBBLES WERE PRESENT IN SEVERAL VACUTAINERS BEFORE USE. VERBIAGE: IMMEDIATELY AFTER THE SITE INITIATION VISIT FOR AN INTERNAL BD STUDY, THE ABOVE MENTIONED TUBES WERE FOUND TO APPEAR DEFECTIVE, I.E., THE BARRIER GEL HAS VOIDS AND/OR BUBBLES. AS THIS STUDY IS SPECIFICALLY EXAMINING HOW WELL THE GEL BARRIER PERFORMS DURING SIMULATED SHIPPING OVER SHELF LIFE, IT WAS FELT THAT THIS "DEFECT" MAY AFFECT THE STUDY RESULTS AND WERE REMOVED AND REPLACED WITH TUBES FROM THE SAME LOT THAT APPEAR NORMAL. CATALOG #: 367985, LOT #: 9172620, EXPIRATION DATE: 30 JUNE 2020. CATALOG #: 367985, LOT #: 9172621, EXPIRATION DATE: 30 JUNE 2020.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9172621. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-06-21. MEDICAL DEVICE LOT #: 9172620. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-06-21. 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 8 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED AN AIR BUBBLE WITHIN A TUBE OR GAS SYRINGE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367985, BATCH NO. 9172620 AND 9172620. IT WAS REPORTED AIR BUBBLES WERE PRESENT IN SEVERAL VACUTAINERS BEFORE USE. VERBIAGE: IMMEDIATELY AFTER THE SITE INITIATION VISIT FOR AN INTERNAL BD STUDY, THE ABOVE MENTIONED TUBES WERE FOUND TO APPEAR DEFECTIVE, I.E. THE BARRIER GEL HAS VOIDS AND/OR BUBBLES. AS THIS STUDY IS SPECIFICALLY EXAMINING HOW WELL THE GEL BARRIER PERFORMS DURING SIMULATED SHIPPING OVER SHELF LIFE, IT WAS FELT THAT THIS "DEFECT" MAY AFFECT THE STUDY RESULTS AND WERE REMOVED AND REPLACED WITH TUBES FROM THE SAME LOT THAT APPEAR NORMAL. CATALOG #: 367985. LOT #: 9172620. EXPIRATION DATE: 30 JUNE 2020. CATALOG #: 367985. LOT #: 9172621. EXPIRATION DATE: 30 JUNE 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722005 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903679855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other