BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 9372640 · Received November 25, 2019

    Report

    Report Number
    1024879-2019-02041
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 7, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903672900
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SLEEVE FALL OFF OCCURRED DURING USE WITH A BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IN TRAINING ON VACUUM COLLECTION AND SINGLE-USE LUER ADAPTER, BD VACUTAINER ECLIPSE NEEDLE AND HOLDER PRODUCTS, THERE WAS A REPORT OF QUALITY DEVIATION IN LUER ADAPTER PERFORMANCE. A NURSING TECHNICIAN REPORTED THAT DURING A BLOOD DRAW USING THE LUER ADAPTER (LOT 9142877), IN A SINGLE-USE HOLDER (UNKNOWN LOT), AT THE END OF BD VACUTAINER SST TUBE COLLECTION (UNKNOWN LOT) HAPPENED FROM THE DEVICE THAT COVERS THE LUER ADAPTER NEEDLE COMES OUT ALONG THE TUBE CAP AT THE END OF THE COLLECTION, STILL IN THE FIRST TUBE. ADDITIONAL INFORMATION: THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THERE WAS NO EXPOSURE OF BLOOD OR CHEMOTHERAPIC TO THE SKIN/MUCOUS. THE SAMPLE WAS DISCARDED BY THE CUSTOMER."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SLEEVE FALL OFF OCCURRED DURING USE WITH A BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IN TRAINING ON VACUUM COLLECTION AND SINGLE-USE LUER ADAPTER, BD VACUTAINER ECLIPSE NEEDLE AND HOLDER PRODUCTS, THERE WAS A REPORT OF QUALITY DEVIATION IN LUER ADAPTER PERFORMANCE. A NURSING TECHNICIAN REPORTED THAT DURING A BLOOD DRAW USING THE LUER ADAPTER (LOT 9142877), IN A SINGLE-USE HOLDER (UNKNOWN LOT), AT THE END OF BD VACUTAINER SST TUBE COLLECTION (UNKNOWN LOT) HAPPENED FROM THE DEVICE THAT COVERS THE LUER ADAPTER NEEDLE COMES OUT ALONG THE TUBE CAP AT THE END OF THE COLLECTION, STILL IN THE FIRST TUBE. ADDITIONAL INFORMATION: THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THERE WAS NO EXPOSURE OF BLOOD OR CHEMOTHERAPIC TO THE SKIN/MUCOUS. THE SAMPLE WAS DISCARDED BY THE CUSTOMER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168037 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9142877 50382903672900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other