BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 8926496 · Received August 23, 2019

    Report

    Report Number
    9617032-2019-00967
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 3, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. SAMPLES AND A PHOTO WERE EVALUATED FOR LOT 9023840 AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, A PHOTO WAS RECEIVED FOR LOT 8291824 IN WHICH FOREIGN MATTER WAS ALSO OBSERVED. 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 SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FM ON NEEDLE. CUSTOMER FOUND GREEN PARTICLE ON NEEDLE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9023840. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-01-23. MEDICAL DEVICE LOT #: 8291824. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. DEVICE MANUFACTURE DATE: 2018-10-18.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FM ON NEEDLE. CUSTOMER FOUND GREEN PARTICLE ON NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722186 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other