BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 17435389 · Received August 1, 2023

    Report

    Report Number
    9617032-2023-01006
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 25, 2023
    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.6. 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. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. E.1. INITIAL REPORTER ADDR 1: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES THERE WERE ERRONEOUS RESULTS. THIS IT THE 1ST OF 2 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WERE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES? YES . DETAILED ERROENOUS RESULTS: NA >250 REPEAT 143 . 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. 1. WERE ANY WRONG RESULTS REPORTED TO THE DOCTORS? NO. A. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. B. IF YES, DID THE WRONG TREATMENT HARM THE PATIENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555216 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown