BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 19GA 1-1/2IN TW

    MDR report key: 9178447 · Received October 11, 2019

    Report

    Report Number
    3002682307-2019-00542
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 18, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A SAMPLE FOR CATALOG 301500 LOT 190322 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE AFFECTED NEEDLE SHOW A CANNULA TOTALLY DETACHED FROM THE HUB WITH VERY FEW RESIDUES OF EPOXY ON CANNULA NOT IN HUB. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. CONCLUSION: DURING THE CANNULA ASSEMBLY PROCESS, THE POSSIBLE ROOT CAUSES MAY HAVE BEEN AN INAPPROPRIATE DOSAGE OR A EPOXY NOZZLE ADJUSTMENT OR REPLACEMENT. THIS IS A VERY UNUSUAL CIRCUMSTANCE BECAUSE THE NEEDLES ARE 100% INSPECTED FOR PRESENCE OF EPOXY IN THE MANUFACTURING PROCESS, REJECTING ANY NEEDLE WITH ABSENCE OR IMPROPER AMOUNT OF ADHESIVE. THIS CAMERA SYSTEM IS CHALLENGED EVERY 8 WORKING HOURS AT THE BEGINNING OF EVERY SHIFT. BASED ON THE PREVENTIVE MEASURES AND BD'S STRINGENT SAMPLING INSPECTION, BD IS CERTAIN THIS IS A ISOLATED INCIDENT. AS THIS IS THE FIRST TIME THIS LOT HAS BEEN REPORTED, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE CONNECTIVITY ISSUE OCCURRED DURING USE WITH A NEEDLE 19GA 1-1/2IN TW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN ATTEMPTING TO REMOVE SOLUTE FROM A VIAL OF PROPOFOL DURING ANESTHESIA INDUCTION, THE NEEDLE DISENGAGED FROM THE BASE. PLASTIC."

    Additional Manufacturer Narrative · 1

    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 A NEEDLE CONNECTIVITY ISSUE OCCURRED DURING USE WITH A NEEDLE 19GA 1-1/2IN TW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN ATTEMPTING TO REMOVE SOLUTE FROM A VIAL OF PROPOFOL DURING ANESTHESIA INDUCTION, THE NEEDLE DISENGAGED FROM THE BASE. PLASTIC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976906 NEEDLE 19GA 1-1/2IN TW NEEDLE FMI BECTON DICKINSON, S.A. 190322

    Patients

    Seq Age Sex Outcome Treatment
    1 Other