BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 9732261 · Received February 20, 2020

    Report

    Report Number
    9617032-2020-00152
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    January 20, 2020
    Report Date
    April 28, 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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/24/2020. H.6. INVESTIGATION: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR GEL AIR BUBBLES WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND GEL AIR BUBBLES WAS OBSERVED. 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 WAS REPORTED THAT SMALL OIL GEL GLOBULES WERE FOUND IN THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE'S SERUM DURING USE AFTER RECEIVING AN ASPIRATION ERROR ON THE INSTRUMENT. THE "NON-REFRIGERATED" SAMPLE WAS CENTRIFUGED ON A "ROTINA 48" AT "2060 RCF FOR 10 MINUTES". THIS OCCURRED ON 40 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MINISCULE GEL GLOBULES IN SERUM. THE CUSTOMER IS EXPERIENCING AN INCREASED INCIDENCE OF ASPIRATION ERRORS ON THE INSTRUMENT. +/-10% OF DALIY WORKLOAD OF 400 PDAY. ON INSPECTION OF THE REJECTED SAMPLES MINUSCULE GEL GLOBULES WERE OBSERVED IN SOME OF THE SAMPLES. (UNFORTUNATELY IT WAS NOT POSSIBLE TO CAPTURE AN IMAGE OF THE GLOBULES)THE CUSTOMER REPORTED A SIMILAR ISSUE AT THE SAME TIME LAST YEAR.- (PIR 2009992) ON THIS OCCASION THERE WAS NO SIGNIFICANT GEL SMEARING OBSERVED.THE CUSTOMER HAS INSTALLED ABBOTT ALINITY C AND ALINITY I IN SEPTEMBER 2019.ALL OTHER WORKFLOW PROCESSES ARE THE SAME.CENTRIFUGE USED - ROTINA 48(NON REFRIGERATED) SAMPLES CENTRIFUGED AT 2060 RCF FOR 10 MINUTES.

    Additional Manufacturer Narrative · 1

    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 THAT SMALL OIL GEL GLOBULES WERE FOUND IN THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE'S SERUM DURING USE AFTER RECEIVING AN ASPIRATION ERROR ON THE INSTRUMENT. THE "NON-REFRIGERATED" SAMPLE WAS CENTRIFUGED ON A "ROTINA 48" AT "2060 RCF FOR 10 MINUTES". THIS OCCURRED ON 40 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MINISCULE GEL GLOBULES IN SERUM. THE CUSTOMER IS EXPERIENCING AN INCREASED INCIDENCE OF ASPIRATION ERRORS ON THE INSTRUMENT. +/-10% OF DAILY WORKLOAD OF 400 PDAY. ON INSPECTION OF THE REJECTED SAMPLES MINUSCULE GEL GLOBULES WERE OBSERVED IN SOME OF THE SAMPLES. (UNFORTUNATELY IT WAS NOT POSSIBLE TO CAPTURE AN IMAGE OF THE GLOBULES)THE CUSTOMER REPORTED A SIMILAR ISSUE AT THE SAME TIME LAST YEAR.- (PIR (B)(4)) ON THIS OCCASION THERE WAS NO SIGNIFICANT GEL SMEARING OBSERVED. THE CUSTOMER HAS INSTALLED ABBOTT ALINITY C AND ALINITY I IN (B)(6) 2019. ALL OTHER WORKFLOW PROCESSES ARE THE SAME. CENTRIFUGE USED - ROTINA 48(NON REFRIGERATED) SAMPLES CENTRIFUGED AT 2060 RCF FOR 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199559 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9189867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other