BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 13211390 · Received January 10, 2022

    Report

    Report Number
    9617032-2021-01373
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    December 13, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 #: 1274534. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2021-10-01. MEDICAL DEVICE LOT #: 1242128. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2021-08-30. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT A VIDEO WAS PROVIDED FOR INVESTIGATION. THE VIDEO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR SPLASHING WHEN REMOVING THE CLOSURE WAS OBSERVED. OVERFILL WAS NOT OBSERVED. ADDITIONALLY, TWENTY (20) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF OVERFILL WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF SPLASHING BUT THERE IS NO EVIDENCE THAT IT OCCURRED AS A RESULT OF A DEFECT WITH THE TUBE. THE COMPLAINT COULD NOT BE CONFIRMED FOR OVERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED SAMPLE LEAKAGE AND OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: SPLASH WHEN REMOVE CLOSURE (CAP). WHEN THE TUBE IS COMPLETELY NEW ( FRESH) FROM PRODUCTION THE CUSTOMER FEELS THAT THERE IS A SPLASH WHEN THE INSTRUMENT REMOVE THE CLOSURE. THERE ARE ALSO SAME THING WITH LOT 1242128. THE TUBES ARE FRESH ( LOT OF VACUUM) AND FILED 10% OVER OPTIMAL VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630123 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1242128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown