BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    MDR report key: 9430631 · Received December 6, 2019

    Report

    Report Number
    2243072-2019-02745
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 21, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, 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 THE TUBE IS PUSHED OFF THE NEEDLE WITH A BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) FIRST TUBE GETS PUSHED OFF THE ECLIPSE SIGNAL NEEDLE. COMPLAINT HAS BEEN REPORTED SEVERAL TIMES BEFORE, BUT THIS TIME LOT NUMBERS WERE REPORTED TOO. ECLIPSE NEEDLE IN COMBINATION WITH RST TUBE.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 190411, MEDICAL DEVICE EXPIRATION DATE: 2020-06-30, DEVICE MANUFACTURE DATE: 2019-10-16, MEDICAL DEVICE LOT #: 190316, MEDICAL DEVICE EXPIRATION DATE: 2020-05-31, DEVICE MANUFACTURE DATE: 2019-09-25, " INITIAL REPORTER PHONE #: UNKNOWN. 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 THAT THE TUBE IS PUSHED OFF THE NEEDLE WITH A BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) FIRST TUBE GETS PUSHED OFF THE ECLIPSE SIGNAL NEEDLE. COMPLAINT HAS BEEN REPORTED SEVERAL TIMES BEFORE, BUT THIS TIME LOT NUMBERS WERE REPORTED TOO. ECLIPSE NEEDLE IN COMBINATION WITH RST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228932 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 368774 SEE H.10 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other