BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9716950 · Received February 17, 2020

    Report

    Report Number
    1024879-2020-00103
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 28, 2020
    Report Date
    April 28, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR GEL AIRBUBBLES WITH THE INCIDENT LOT WAS OBSERVED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES/"VOIDS" WERE FOUND IN THE GEL OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BEFORE USE. THE AIR BUBBLES REPORTEDLY RANGED IN SIZE FROM "5 TO 9 MM". LOT# 9172620 WAS REPORTED TO HAVE HAD 9 OCCURRENCES OF THIS EVENT, WHILE LOT# 9172621 WAS REPORTED TO HAVE HAD 6 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BARRIER GEL FOR THESE TUBES FOUND TO HAVE LARGE BUBBLES/VOIDS. SIZE AVERAGING FROM 5 TO 9 MM. NO VENIPUNCTURES WERE PERFORMED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9172620. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-06-21. MEDICAL DEVICE LOT #: 9172621. 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 AIR BUBBLES/"VOIDS" WERE FOUND IN THE GEL OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BEFORE USE. THE AIR BUBBLES REPORTEDLY RANGED IN SIZE FROM "5 TO 9 MM". LOT# 9172620 WAS REPORTED TO HAVE HAD 9 OCCURRENCES OF THIS EVENT, WHILE LOT# 9172621 WAS REPORTED TO HAVE HAD 6 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BARRIER GEL FOR THESE TUBES FOUND TO HAVE LARGE BUBBLES/VOIDS. SIZE AVERAGING FROM 5 TO 9 MM. NO VENIPUNCTURES WERE PERFORMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181966 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367985 SEE SECTION H.10. 50382903679855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other