BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBE

    MDR report key: 10305592 · Received July 21, 2020

    Report

    Report Number
    2243072-2020-01111
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 31, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: D.1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBE; D.3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. ¿ BROKEN BOW, NE / 68822; D.4 MEDICAL DEVICE CATALOG #: 367962. THERE WAS A LOT NUMBER THAT WAS POSSIBLY REPORTED TO BE INVOLVED. D.4. MEDICAL DEVICE LOT #: 9344006; D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-12-31; H.4. DEVICE MANUFACTURE DATE: 2019-12-10. G.2 MANUFACTURING LOCATION: BECTON, DICKINSON & CO. ¿ BROKEN BOW, NE / 68822; G.5. PMA / 510(K)#: K945952.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED AFTER USE WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (6 OF 25 COMPLAINTS); IT IS REPORTED IN BECKMAN COULTER STUDY ERRONEOUS RESULTS WERE REPORTED. INITIAL RESULT; 612.3. ADDITIONALLY, ON 2020-07-14 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: ¿I HAVE SOME ADDITIONAL CLARIFICATIONS TO YOUR QUESTIONS. ¿ 1ST I HAVE ATTACHED THE LOT NUMBERS OF THE TUBES USED BY THE CUSTOMER. THE CHECKMARK AFTER THE GOLD AND IN FRONT OF THE LOT # CONFIRM THE TUBES KNOWN TO BE RUN ON THE INVESTIGATED SAMPLES. THE LOT #¿S IN BLACK TYPE ARE KNOWN TO BE IN HOUSE AT THE CLINIC WHERE THE SPECIMENS FROM THE IVF WERE MOST LIKELY DRAWN. THE HANDWRITTEN BLUE LOT #¿S OR CHECKMARKS AFTER THE LOT # ARE LOT #¿S IN HOUSE. THE SAMPLES WERE REFRIGERATED 2-8 DEGREES MANUAL RACK OR 2-8 DEGREES AUTOMATION STOCK YARD AFTER RUNNING. #1 PATIENT IS A PST TUBE. THE TUBES ARE PROCESSED: MIXED 10 TIMES UPON DRAWING, CLOT TIME FOR GOLD AND RED IS 30 MINUTES AND CENTRIFUGED. SST AND RED TOPS AT 10 MINUTES AT 3655 AND PST AT 5 MINUTES AT 3655, AUTOMATION LINE SPINS AT 3000 FOR 4, ALL SWING CENTRIFUGES. (THIS INFORMATION IS STILL BEING CONFIRMED AND WILL SEND YOU AN UPDATE AS SOON AS I HAVE ONE). GO IS GOLD TOP TUBES.¿. ADDITIONALLY, ON 2020-07-23 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CONFIRMED THAT THE LOT NUMBERS PROVIDED WAS KNOWN TO BE IN STOCK AT THE TIME. THEY ARE NOT CAPABLE OF FINDING OUT WHICH SPECIFIC LOT WAS USED FOR EACH INDIVIDUAL ERRONEOUS RESULT REPORTED. NO FURTHER INFORMATION IS KNOWN NOR ARE SAMPLES AVAILABLE.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: THIS INVESTIGATION WILL BE CLOSED WITHOUT FURTHER INVESTIGATION SINCE THE MATERIAL NUMBER AND LOT NUMBER ARE UNKNOWN. AT THIS TIME, BD DOES NOT HAVE ENOUGH INFORMATION TO FURTHER INVESTIGATE THIS ISSUE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. COMPLAINTS RECEIVED 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 · 1

    IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED AFTER USE WITH AN UNSPECIFIED BD PST BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (6 OF 25 COMPLAINTS) IT IS REPORTED IN BECKMAN COULTER STUDY ERRONEOUS RESULTS WERE REPORTED. INITIAL RESULT; 612.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770125 BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other