BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 12594937 · Received October 7, 2021

    Report

    Report Number
    9617032-2021-01044
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 9, 2021
    Report Date
    October 29, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES . D.9. RETURNED TO MANUFACTURER ON: 10/29/2021. H.6. INVESTIGATION: BD RECEIVED SIXTY-EIGHT (68) SAMPLES AND EIGHT (8) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER (FM) WAS OBSERVED. TEN (10) OF THE RETURNED CUSTOMER SAMPLES WERE RANDOMLY SELECTED AND VISUALLY INSPECTED FOR FM WITH NONE OBSERVED. A RETURNED UNUSED SAMPLE, WHICH WAS CONNECTED WITH THE HOLDER WAS VISUALLY INSPECTED AND BLACK FM WAS OBSERVED. ADDITIONALLY, ONE HUNDRED (100) RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND UPON COMPLETION THE INDICATED FAILURE MODE FOR FM WAS NOT OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF FM BASED ON RETURN PHOTOS AND SAMPLE. BD WAS ABLE TO DETERMINE THAT THE FM WAS ATTRIBUTED TO THE HUB SPRUE SEPARATION PROCESS. THE TEARING OF THE SPRUE FROM THE HUBS CAN CREATE SMALL PLASTIC PARTICLES THAT ARE COLLECTED WITH THE HUBS AND INTRODUCED TO THE MULTI-SAMPLE NEEDLE (MSN) ASSEMBLY LINE. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF FM THROUGH CAPA#1240118.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE, THE DEVICE EXPERIENCED FOREIGN MATTER ON THE DEVICE NEEDLE. THIS EVENT OCCURRED FIVE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED THAT DUST/DIRT-LIKE SOMETHING WAS FOUND ONTO THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE, THE DEVICE EXPERIENCED FOREIGN MATTER ON THE DEVICE NEEDLE. THIS EVENT OCCURRED FIVE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED THAT DUST/DIRT-LIKE SOMETHING WAS FOUND ONTO THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488691 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 0035829

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown