BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 12281354 · Received August 5, 2021

    Report

    Report Number
    9617032-2021-00866
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 15, 2021
    Report Date
    July 20, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679534
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 #: 0240262. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2020-08-27. MEDICAL DEVICE LOT #: 0314719. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2020-11-09. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT A PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR 'UNDERFILL' WITH THE INCIDENT LOT WAS NOT OBSERVED. THE PHOTO APPEARED TO SHOW AN UNUSED TUBE. ADDITIONALLY, 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.

    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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THEY ARE "HAVING ISSUES GETTING ENOUGH AMOUNT OF SERUM" IN THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181149 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367953 SEE H.10 50382903679534

    Patients

    Seq Age Sex Outcome Treatment
    1