BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 16593435 · Received March 22, 2023

    Report

    Report Number
    1213809-2023-00251
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 10, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2024137. D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. H4: DEVICE MANUFACTURE DATE: 24-JAN-2022. D4: MEDICAL DEVICE LOT #: 0156541. D4: MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. H4: DEVICE MANUFACTURE DATE: 04-JUN-2020. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 29-MAR-2023. IT WAS REPORTED THAT THE NEEDLES WERE CLOGGED. TO AID IN THE INVESTIGATION, THREE HUNDRED TWENTY SAMPLES FROM LOT 2024137 AND NINE SAMPLES FROM LOT 0156541 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. EIGHTY SAMPLES WERE RANDOMLY SELECTED 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. SEVENTY-EIGHT SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. TWO SAMPLES FROM LOT 2024137 DID NOT EXPEL THE SOLUTION; THESE NEEDLES ARE CLOGGED. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2024137 AND 0156541. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. PENNSYLVANIA, USA HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLES HAVE SOMETHING BLOCKING THE AIRWAY TO THE SYRINGES.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLES HAVE SOMETHING BLOCKING THE AIRWAY TO THE SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456404 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H10 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown