BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E

    MDR report key: 12021895 · Received June 17, 2021

    Report

    Report Number
    1917413-2021-00524
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 26, 2021
    Report Date
    August 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    50382903627887
    PMA / PMN Number
    K972075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS AND 2 VIDEOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS/VIDEOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR OIL GEL GLOBULES WAS NOT OBSERVED WITH BD PRODUCT 362788. THE PHOTOS SHOW A YELLOW/BROWN SUBSTANCE IN THE BOTTOM OF TRAY WITH 96 CAVITIES. THIS IS NOT HOW THE TUBE IS PRESENTING WHEN PACKED AT THE MANUFACTURING SITE. NO OIL GEL GLOBULES OR POOR SERUM/PLASMA IN PPT TUBES CAN BE SEEN IN THESE PHOTOS. THERE HAVE BEEN NO CHANGES TO THE RAW MATERIALS OR PROCESSES USED TO MANUFACTURE THIS PRODUCT. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO OIL GEL GLOBULES WERE OBSERVED. 75 RETENTION SAMPLES WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE, SAMPLE QUALITY/OIL GEL GLOBULES, BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. VISUAL EVALUATIONS OF BOTH RETAIN AND CONTROL SAMPLES FOR SAMPLE QUALITY/OIL GEL GLOBULES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL OBSERVATIONS. 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 IS NOT CONFIRMED WITH RESPECT TO SAMPLE QUALITY/OIL GEL GLOBULES.. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E, THE DEVICE EXPERIENCED OIL GEL GLOBULES. THIS EVENT OCCURRED 96 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: GEL FORMATION WAS OBSERVED COMING FROM THE BLOOD BANK OF ONE OF THE UNITS, AS OCCURRED IN 2018 FOR ANOTHER BATCH. AND IT WAS POINTED OUT THAT REDUCING THE TEMPERATURE TO 50 DEGREES CELSIUS IN THIS BATCH CAUSES THE GEL NOT TO BE FORMED. HOWEVER, THIS TEMPERATURE IS NOT IDEAL FOR EXTRACTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E, THE DEVICE EXPERIENCED OIL GEL GLOBULES. THIS EVENT OCCURRED 96 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: GEL FORMATION WAS OBSERVED COMING FROM THE BLOOD BANK OF ONE OF THE UNITS, AS OCCURRED IN 2018 FOR ANOTHER BATCH. AND IT WAS POINTED OUT THAT REDUCING THE TEMPERATURE TO 50 DEGREES CELSIUS IN THIS BATCH CAUSES THE GEL NOT TO BE FORMED. HOWEVER, THIS TEMPERATURE IS NOT IDEAL FOR EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911756 BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON & CO. (BROKEN BOW) 362788 0184330 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1