BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15701905 · Received October 31, 2022

    Report

    Report Number
    1213809-2022-00840
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 6, 2022
    Report Date
    November 14, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2003405. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. DEVICE MANUFACTURE DATE: 03-JAN-2022. MEDICAL DEVICE LOT #: 2003406. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. DEVICE MANUFACTURE DATE: 03-JAN-2022. MEDICAL DEVICE LOT #: 1340735. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2026. DEVICE MANUFACTURE DATE: 06-DEC-2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 31-OCT-2022 H6: INVESTIGATION SUMMARY IT WAS REPORTED THE NEEDLES WERE CLOGGED. TO AID IN THE INVESTIGATION, FIFTEEN SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. THIRTEEN SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. TWO SAMPLES DID NOT EXPEL THE SOLUTION; THESE NEEDLES ARE CLOGGED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2003405, 2003406 AND 1340735. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURE OF LOT 1340735. DURING THE HISTORY REVIEW, ONE LOT WAS IDENTIFIED AS HAVING SUFFERED FROM CLOGGED NEEDLES DUE TO SILICONE. IT COULD BE POSSIBLE SOME SAMPLES ARE ESCAPES FROM THE INCIDENT THAT OCCURRED WHILE PRODUCTION. THE PROCESS TO ISOLATE AFFECTED PRODUCT WAS REVIEWED, AS WELL AS THE PROCESS OF VARIATIONS THAT COULD INDUCE THE NEEDLE CLOGGED / BLOCKED SYMPTOM. THE PROCESSES WERE ADJUSTED TO PREVENT VARIATIONS THAT COULD RESULT IN THIS DEFECT. BASED ON THE QUALITY TEAM¿S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT CLOGGED NEEDLE CAN BE TRACED TO THE MANUFACTURING PROCESS. DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SAFETYGLIDE¿ NEEDLE EACH FROM LOTS 2003405, 2003406, AND 1340735 WERE CLOGGED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE HAS BEEN NOTED TO BE CLOGGED, THE PLUNGER IS UNABLE TO DEPRESS".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SAFETYGLIDE¿ NEEDLE EACH FROM LOTS 2003405, 2003406, AND 1340735 WERE CLOGGED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE HAS BEEN NOTED TO BE CLOGGED, THE PLUNGER IS UNABLE TO DEPRESS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2952637 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H10 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown