BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 13231854 · Received January 11, 2022

    Report

    Report Number
    9617032-2021-01390
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 9, 2021
    Report Date
    March 21, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1245658 . MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2021-09-02. MEDICAL DEVICE LOT #: 1284357. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2021-10-11. MEDICAL DEVICE LOT #: 1203646. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2021-07-22. MEDICAL DEVICE LOT #: 1061232. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-03-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. IF SAMPLES ARE RECEIVED AT A LATER DATE THE RECORD WILL BE REOPENED AND INVESTIGATED ACCORDINGLY. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO UNDERFILL AND ERRONEOUS RESULTS WERE OBSERVED. 20 RETAINED SAMPLES FROM EACH LOT NUMBER: 1245658, 1284357, 1203646, 1061232 WERE DRAW-TESTED WITH DEIONIZED WATER. FROM THIS TESTING IT WAS DETERMINED THAT ALL 80 TUBES DREW WITHIN SPECIFICATION. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE, UNDERFILL BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. THE CUSTOMER HAS STATED THAT THEY FELT THE ERRONEOUS IONIZED CALCIUM RESULTS OBTAINED WERE A DIRECT RESULT OF THE SPACE ABOVE THE SAMPLE. THIS INVESTIGATION HAS NOT CONFIRMED THE REPORTED UNDERFILL THEY FELT WAS THE CAUSE OF THE ABERRANT RESULTS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL AND ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND ERRONEOUS RESULTS. THE UNDERFILL EVENT AFFECTED 2400 DEVICES. THE ERRONEOUS RESULTS EVENT AFFECTED 2400 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE IS "UNDERFILLING OF TUBES. TUBES TEND TO UNDERFILL, MANY LOTS TESTED AND THE RESULT IS THAT IONIZED CALCIUM IS OUT OF MEASURABLE RANGE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND ERRONEOUS RESULTS. THE UNDERFILL EVENT AFFECTED 2400 DEVICES. THE ERRONEOUS RESULTS EVENT AFFECTED 2400 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE IS "UNDERFILLING OF TUBES. TUBES TEND TO UNDERFILL, MANY LOTS TESTED AND THE RESULT IS THAT IONIZED CALCIUM IS OUT OF MEASURABLE RANGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738014 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1061232

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown