BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE ONLY, 5/8 IN., 25 G

    MDR report key: 15341521 · Received September 1, 2022

    Report

    Report Number
    1213809-2022-00536
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 5, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059010
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL: YES. D.10. RETURNED TO MANUFACTURER ON: 19-AUG-2022. H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON SAMPLE INSPECTION, NO NEEDLE CLOGGED DEFECT WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1152490. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 5/8 IN., 25 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS SOME ISSUES WITH SYRINGES/NEEDLES NOT DRAWING (CLOGGED/BLOCKED).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 5/8 IN., 25 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS SOME ISSUES WITH SYRINGES/NEEDLES NOT DRAWING (CLOGGED/BLOCKED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201162 BD SAFETYGLIDE¿ NEEDLE ONLY, 5/8 IN., 25 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 1152490 00382903059010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown