BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15801914 · Received November 15, 2022

    Report

    Report Number
    1213809-2022-01005
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 3, 2022
    Report Date
    January 6, 2023
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2025238, MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, DEVICE MANUFACTURE DATE: 25-JAN-2022. MEDICAL DEVICE LOT #: 2003405, MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, DEVICE MANUFACTURE DATE: 03-JAN-2022. 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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR BATCH NUMBER 2025238 AND 2003405. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE BATCHES WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH LOT OF NEEDLES USED IN THE MANUFACTURE OF THESE BATCHES. DURING THE HISTORY REVIEW, ONE LOT FROM BATCH 2025238 WAS IDENTIFIED AS HAVING SUFFERED FROM CLOGGED NEEDLES DUE TO SILICONE. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SAFETYGLIDE¿ NEEDLE FROM LOT 2025238, AND 15 BD SAFETYGLIDE¿ NEEDLES FROM LOT 2003405 WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLES FEELING CLOGGED AND DIFFICULT TO PUSH OUT." "RESISTANCE ISSUE WHERE NEEDLES FEEL BLOCKED OR INCREASED RESISTANCE MET AND UNABLE TO RELEASE PLUNGER AND MEDICATION WHEN ATTEMPTING TO INJECT"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SAFETYGLIDE¿ NEEDLE FROM LOT 2025238, AND 15 BD SAFETYGLIDE¿ NEEDLES FROM LOT 2003405 WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLES FEELING CLOGGED AND DIFFICULT TO PUSH OUT." "RESISTANCE ISSUE WHERE NEEDLES FEEL BLOCKED OR INCREASED RESISTANCE MET AND UNABLE TO RELEASE PLUNGER AND MEDICATION WHEN ATTEMPTING TO INJECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172771 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H10 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown