BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15442014 · Received September 16, 2022

    Report

    Report Number
    1213809-2022-00582
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 23, 2022
    Report Date
    October 3, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479248561
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1244726. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026. DEVICE MANUFACTURE DATE: 01-SEP-2021. MEDICAL DEVICE LOT #: 2005672. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. DEVICE MANUFACTURE DATE: 05-JAN-2022. MEDICAL DEVICE LOT #: 1180363. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026. DEVICE MANUFACTURE DATE: 29-JUN-2021.

    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: 06-OCT-2022. H.6. INVESTIGATION SUMMARY: THIRTY FOUR SEALED SAMPLES AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON PHOTO EVALUATION, IT WAS OBSERVED THAT THE NEEDLE IS BENT AND PULLED OUT OF THE ITS HUB. PHYSICAL SAMPLES VISUAL INSPECTION WAS PERFORMED WITH 30X MICROSCOPE. NO DAMAGE, DEFECTIVE GRIND OR HOOKS WERE OBSERVED. THE BEVELS AND ETCH WERE GOOD. EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS: 1244726, 2005672 AND 1180363. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. BASED ON THE INVESTIGATION WITH THE SAMPLE ANALYSIS THE SYMPTOMS REPORTED COULD NOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD SAFETYGLIDE¿ NEEDLES CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THEY ARE ADDING SAFETY NEEDLE TO PRE DRAWN SYRINGE THEY ARE UNABLE TO REMOVE THE AIR, NOTHING COMES OUT OF NEEDLE, THERE IS TOO MUCH PRESSURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD SAFETYGLIDE¿ NEEDLES CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THEY ARE ADDING SAFETY NEEDLE TO PRE DRAWN SYRINGE THEY ARE UNABLE TO REMOVE THE AIR, NOTHING COMES OUT OF NEEDLE, THERE IS TOO MUCH PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177581 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 192-N2558S SEE H.10 10612479248561

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown