BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PRECISIONGLIDE MULTIPLE SAMPLE NEEDLE

    MDR report key: 11586359 · Received March 29, 2021

    Report

    Report Number
    9617032-2021-00285
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 5, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLE AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND A SMALL, GREEN PIECE OF PLASTIC ADHERING TO THE IV CANNULA WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND THE PIECE OF PLASTIC ADHERING TO THE IV CANNULA WAS OBSERVED. 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF FOREIGN MATTER THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. CAPA 1240118 HAS BEEN INITIATED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE/TUBING OR ANY FLUID PATH COMPONENT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER "FOUND A GREEN PARTICLE ON THE PATIENT SIDE OF THE NEEDLE."

    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 WHEN USING THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE/TUBING OR ANY FLUID PATH COMPONENT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER "FOUND A GREEN PARTICLE ON THE PATIENT SIDE OF THE NEEDLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482841 BD VACUTAINER PRECISIONGLIDE MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 0120765

    Patients

    Seq Age Sex Outcome Treatment
    1