BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 17421348 · Received July 28, 2023

    Report

    Report Number
    9617032-2023-00966
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 24, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. E.1 INITIAL REPORTER ADDR 1: (B)(6).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES LARGE INCREASE IN THE INCIDENCE OF SODIUM FLYERS ON THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE HAVE SEEN A LARGE INCREASE IN THE INCIDENCE OF SODIUM FLYERS ON THE VITROS IN OUR REGIONAL LABS USING PST TUBES. QUIDEL-ORTHO HAVE INVESTIGATED AND SUGGEST THE ISSUE COULD BE RELATED TO THE VACUTAINERS ¿ EITHER THE CENTRIFUGATION SPEEDS OR THE GEL INTEGRITY. THIS IS ESPERANCE LABORATORY. ERRONEOUS RESULT NA>250 REPEAT 140.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES LARGE INCREASE IN THE INCIDENCE OF SODIUM FLYERS ON THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE HAVE SEEN A LARGE INCREASE IN THE INCIDENCE OF SODIUM FLYERS ON THE VITROS IN OUR REGIONAL LABS USING PST TUBES. QUIDEL-ORTHO HAVE INVESTIGATED AND SUGGEST THE ISSUE COULD BE RELATED TO THE VACUTAINERS ¿ EITHER THE CENTRIFUGATION SPEEDS OR THE GEL INTEGRITY. THIS IS ESPERANCE LABORATORY. ERRONEOUS RESULT NA>250 REPEAT 140.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966249 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNONW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown