BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 9262717 · Received October 31, 2019

    Report

    Report Number
    9617032-2019-01239
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS AND SAMPLES WERE EVALUATED AND IT SHOWED THE TUBES WITH LARGER THAN NORMAL DROPLETS OF SILICA SUSPENSION ON THE TUBE WALL. THIS IS RECOGNIZED TO BE AN AESTHETIC DEFECT WITH NO IMPACT ON THE EFFICACY OF THE TUBE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT FROM PRIVATE LABORATORY. THE USER COMPLAINED THAT WHITE SPOTS WERE FOUND ON THE TUBE.

    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 #: 9057553. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2019-02-26. MEDICAL DEVICE LOT #: 9084743. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2019-03-25. MEDICAL DEVICE LOT #: 9092639. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31. DEVICE MANUFACTURE DATE: 2019-04-02. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT FROM PRIVATE LABORATORY. THE USER COMPLAINED THAT WHITE SPOTS WERE FOUND ON THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059078 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Other