BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE

    MDR report key: 10532680 · Received September 14, 2020

    Report

    Report Number
    1917413-2020-00814
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 12, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903680561
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO CUSTOMER SAMPLES FROM LOT 0072540 AND 2 PHOTOS WERE RETURNED FROM THE CUSTOMER FACILITY FOR EVALUATION. NO SAMPLES WERE RECEIVED FROM LOT 0100294. THE SAMPLES AND PHOTOS DO SHOW THE CUSTOMER¿S FAILURE MODE OF FOREIGN MATTER. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED IN TUBES WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES. THIS OCCURRED WITH 2 TUBES FROM LOT# 0072540 PRIOR TO USE, AND 1 TUBE WITH LOT# 0100294 AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER WITNESSED UNKNOWN FOREIGN BLACK MATTER IN TUBES; AFTER AND BEFORE USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0072540. MEDICAL DEVICE EXPIRATION DATE: 2021-03-31. DEVICE MANUFACTURE DATE: 2020-03-12. MEDICAL DEVICE LOT #: 0100294. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2020-04-09. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED IN TUBES WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES. THIS OCCURRED WITH 2 TUBES FROM LOT# 0072540 PRIOR TO USE, AND 1 TUBE WITH LOT# 0100294 AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER WITNESSED UNKNOWN FOREIGN BLACK MATTER IN TUBES; AFTER AND BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997219 BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 368056 SEE H.10 50382903680561

    Patients

    Seq Age Sex Outcome Treatment
    1 Other