BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G

    MDR report key: 15700743 · Received October 31, 2022

    Report

    Report Number
    1911916-2022-00599
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 6, 2022
    Report Date
    November 3, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051069
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 01-NOV-2022. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE NEEDLE IS NOT PUSHING THE FLUID THROUGH. TO AID IN THE INVESTIGATION, EIGHT HUNDRED SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE HUNDRED TWENTY-FIVE SAMPLES WERE RANDOMLY SELECTED. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT NUMBER 2004758. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 200748 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE DOCTOR IS ADMINISTRATING THE LIDOCAINE INJECTION TO THE PATIENT, THE NEEDLE IS NOT PUSHING THE FLUID THROUGH, CAUSING THE DOCTOR TO STICK THE PATIENT AGAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE DOCTOR IS ADMINISTRATING THE LIDOCAINE INJECTION TO THE PATIENT, THE NEEDLE IS NOT PUSHING THE FLUID THROUGH, CAUSING THE DOCTOR TO STICK THE PATIENT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2951797 BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 00382903051069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown