BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 9467326 · Received December 13, 2019

    Report

    Report Number
    9617032-2019-01455
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 28, 2019
    Report Date
    January 13, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO OIL GEL GLOBULES AS ALL SAMPLES MET SPECIFICATIONS. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING 18300 OCCURRENCES OF CONTAINING OIL GLOBULES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE GEL WAS FOUND FLOATING IN THE SERUM AND ALSO CLOGGED THE ASPIRATION PROBE OF ANALYZER.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9127583. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31. DEVICE MANUFACTURE DATE: 2019-05-07. MEDICAL DEVICE LOT #: 9091636. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2019-04-01. MEDICAL DEVICE LOT #: 9084669. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2019-03-25. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING 18300 OCCURRENCES OF CONTAINING OIL GLOBULES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE GEL WAS FOUND FLOATING IN THE SERUM AND ALSO CLOGGED THE ASPIRATION PROBE OF ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264960 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other