BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE NS 25GA 1IN BLT SQ GRD W/O SHIELD

    MDR report key: 16974416 · Received May 22, 2023

    Report

    Report Number
    1911916-2023-00337
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 3, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4: MEDICAL DEVICE LOT #: 0157518 D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4: DEVICE MANUFACTURE DATE: 05-JUN-2020 D4: MEDICAL DEVICE LOT #: 0113303 D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4: DEVICE MANUFACTURE DATE: 22-APR-2020 H6: INVESTIGATION SUMMARY IT WAS REPORTED THE DEVICES HAD SILICONE COVERAGE. TO AID IN THE INVESTIGATION, TWENTY SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TEN SAMPLES WERE FROM LOT 0113303 IN TWO BAGS. THE UNITS WERE FIVE PER BAG AND THE BAGS WERE NUMBERED 20 AND 25. TEN SAMPLES WERE FROM LOT 0157518 IN TWO BAGS. THE UNITS WERE FIVE PER BAG AND THE BAGS WERE NUMBERED 30 AND 41. EACH UNIT WAS INSPECTED UNDER A 30X MICROSCOPE, AND NO LUBRICANT OR RESIDUES OF LUBRICANT WERE OBSERVED. EACH SAMPLE WAS THEN TESTED FOR RESIDUES FROM THE CLEANING PROCESS AND TESTED USING A WHITE CLOTH CLEANLINESS METHOD AND NO LUBRICANT RESIDUALS WERE FOUND. SAMPLES WERE THEN TESTED BY THE SEM/EDX ANALYSIS USING A GENERAL AREA OF THE NEEDLE FOR ANY ELEMENTAL DIFFERENCES. IN ALL THE UNITS, ONLY STAINLESS STEEL WAS DETECTED. THERE WAS NO SODIUM, POTASSIUM OR LUBRICANT FROM THE SILICONIZATION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301643, LOTS 0113303 AND 0157518. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE REVIEW ALSO CONFIRMED THE LUBRICATION STATION WAS DISCONNECTED WHILE PRODUCING THESE LOTS AND THE INSPECTIONS PERFORMED DETECTED NO LUBRICANT ON THE NEEDLES. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE NS 25GA 1IN BLT SQ GRD W/O SHIELD NON-LUBRICATED DEVICES FAILED TALC POWDER TEST INDICATING THE PRESCIENCE OF LUBRICATION. VERBATIM: NON-LUBRICATED DEVICES FAIL THE TALC POWDER TEST INDICATING THE PRESENCE OF LUBRICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647430 BD NEEDLE NS 25GA 1IN BLT SQ GRD W/O SHIELD HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown