BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 12188967 · Received July 19, 2021

    Report

    Report Number
    9617032-2021-00783
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 23, 2021
    Report Date
    July 23, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION RELATED TO THIS COMPLAINT. THEREFORE, TWENTY (20) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING FOR EACH LOT AND NO ISSUES WERE OBSERVED RELATING TO 'UNDERFILL' AS ALL SAMPLES MET SPECIFICATIONS. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. 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. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE 5ML TUBES WOULD ONLY FILLED TO 4ML."

    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 #: 0072146. MEDICAL DEVICE EXPIRATION DATE: 2021-09-30. DEVICE MANUFACTURE DATE: 2020-03-12. MEDICAL DEVICE LOT #: 0275817. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2020-10-01. 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 WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE 5ML TUBES WOULD ONLY FILLED TO 4ML."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088433 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 SEE H.10 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1