BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 13306875 · Received January 20, 2022

    Report

    Report Number
    8041187-2022-00021
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 28, 2021
    Report Date
    February 18, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0171047. MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. DEVICE MANUFACTURE DATE: 2020-06-19. MEDICAL DEVICE LOT #: 0171114. MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. DEVICE MANUFACTURE DATE: 2020-06-19.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0171047 . MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. DEVICE MANUFACTURE DATE: 2020-06-19. MEDICAL DEVICE LOT #: 0171114. MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. DEVICE MANUFACTURE DATE: 2020-06-19

    Description of Event or Problem · 0

    IT WAS REPORTED THAT (B)(4) BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULAS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITISH PARTICLES ON THE NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2,800 BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULAS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITISH PARTICLES ON THE NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2,800 BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULAS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITISH PARTICLES ON THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491181 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown