BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 8906496 · Received August 19, 2019

    Report

    Report Number
    3002682307-2019-00455
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 4, 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 NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 300600 LOT 190310 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD IS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. 20 RETAINED SAMPLES WERE TESTED IN OUR LAB USING MAGNIFICATION AND DID NOT SHOW ANY CLOGS FOR ANY OF SAMPLES. DEVICE HISTORY AND NEEDLE MANUFACTURING RECORDS SHOWED NO DISCREPANCIES OR ABNORMALITIES. IN CASE AFFECTED SAMPLES ARE RECEIVED IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED. FRAGA PLANT HAS AN IN-LINE CAMERA SYSTEM INSPECTS 100% OF THE NEEDLES LUMEN CONDITION. 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, IT MEANS THAT AN OCCLUSION CONDITION MAY BE PRESENT AND AS A RESULT, THE NEEDLE IS AUTOMATICALLY REJECTED. THIS CAMERA IS CHALLENGED EVERY 8 WORKING HOURS. THESE NEEDLES ARE INSPECTED FOR THE OCCLUDED CANNULA CONDITION AS PART OF THE IN-PROCESS INSPECTION AFTER THE ASSEMBLING PROCESS EVERY 30 MINUTES. AS THIS IS THE FIRST TIME THIS LOT HAS BEEN REPORTED, NO CORRECTIVE ACTIONS ARE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ HYPODERMIC NEEDLE CLOGGED DURING USE WITH THE FIRST INJECTION OF "VIDAZA", AND THE NEEDLE WAS CHANGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: "SUBCUTANEOUS X2 INJECTION OF VIDAZA, DURING THE FIRST INJECTION THE NEEDLE GETS CLOGGED. I HAD TO CHANGE THE NEEDLE. THIS PROBLEM HAS ALREADY BEEN PRESENTED SEVERAL TIMES WITH THE SAME LOT NUMBER TODAY."

    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 THE BD MICROLANCE¿ HYPODERMIC NEEDLE CLOGGED DURING USE WITH THE FIRST INJECTION OF "VIDAZA", AND THE NEEDLE WAS CHANGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: "SUBCUTANEOUS X2 INJECTION OF VIDAZA, DURING THE FIRST INJECTION THE NEEDLE GETS CLOGGED. I HAD TO CHANGE THE NEEDLE. THIS PROBLEM HAS ALREADY BEEN PRESENTED SEVERAL TIMES WITH THE SAME LOT NUMBER TODAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698602 BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 190310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other