BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY

    MDR report key: 9642849 · Received January 29, 2020

    Report

    Report Number
    3002682307-2020-00019
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 8, 2020
    Report Date
    March 25, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    K100209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAS BEEN PROVIDED WITH A PHOTO AND SAMPLES FOR CATALOG 305770 LOT 1904005 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE SAMPLES WAS CONDUCTED AND A WIRE WAS ABLE TO PASS THROUGH THE CANNULA AND DISLODGE THE MATERIAL CLOGGING THE CANNULA ON 3 OF THE 6 SAMPLES. FTIR ANALYSIS WAS COMPLETED ON THE CRYSTALLINE MATERIAL REMOVED FROM THE SAMPLES AND SHOWS THAT THE MATERIAL IS NOT A COMPONENT OF THE ECLIPSE NEEDLE AND COULD HAVE ORIGINATED FROM OUTSIDE THE MANUFACTURING PROCESS. BD WAS ABLE TO VERIFY THE REPORTED ISSUE BUT COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE AS IT RELATES TO THE MANUFACTURING PROCESS. DURING THE CANNULA ASSEMBLING PROCESS, NEEDLES ARE 100% INSPECTED USING A CAMERA SYSTEM. THIS CAMERA SYSTEM SENSES A LIGHT SOURCE WHICH IS POSITIONED AT THE OPPOSITE END OF THE NEEDLE. IF THE CAMERA DOES NOT SENSE THE LIGHT SOURCE, AN OCCLUSION CONDITION MAY BE PRESENT AND AS A RESULT, THE NEEDLE IS AUTOMATICALLY REJECTED. NO OBSTRUCTION WAS DETECTED WHICH ALLOWED THE COMPLETION OF THE NEEDLE TO BE PACKAGED. AS THIS IS THE FIRST TIME THIS LOT HAS BEEN REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NOTHING FLOWED THROUGH THE BD ECLIPSE¿ NEEDLE WITH SMARTSLIP¿ TECHNOLOGY WHEN PRESSING THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PRESSING THE PLUNGER, THERE IS NO FLOW THROUGH THE NEEDLE. SUPPOSEDLY, THE NEEDLE IS OBSTRUCTED." "NEEDLE CHANGE MUST BE ACCOMPLISHED. SECOND PUNCTURE WAS NECESSARY!"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOTHING FLOWED THROUGH THE BD ECLIPSE¿ NEEDLE WITH SMARTSLIP¿ TECHNOLOGY WHEN PRESSING THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PRESSING THE PLUNGER, THERE IS NO FLOW THROUGH THE NEEDLE. SUPPOSEDLY, THE NEEDLE IS OBSTRUCTED." "NEEDLE CHANGE MUST BE ACCOMPLISHED. SECOND PUNCTURE WAS NECESSARY!"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108512 BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1904005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other