BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEM. NEED. 24 X 1

    MDR report key: 10834736 · Received November 13, 2020

    Report

    Report Number
    3002682307-2020-00342
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 20, 2020
    Report Date
    December 2, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0132340 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. ELEVEN PHYSICAL SAMPLES WERE MICROSCOPICALLY EXAMINED AND NO SIGNS OF NEEDLE BURRS WERE OBSERVED. THROUGH VISUAL INSPECTION OF THE FIVE PICTURE SAMPLES, TWO PICTURES REVEALED SOME TYPE OF IMPURITY ON THE CANNULA COMPONENT; HOWEVER, THE PICTURES ARE NOT CLEAR ENOUGH TO CONFIRM THE EXACT ISSUE. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS CANNOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE ASEM. NEED. 24 X 1. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE FOUND MANY IMPURITIES ON THE BODY OF NEEDLE. THESE IMPURITIES CAUSE IRRITATION WHEN APPLYING NEEDLE INSIDE THE PATIENT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE ASEM. NEED. 24 X 1. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE FOUND MANY IMPURITIES ON THE BODY OF NEEDLE. THESE IMPURITIES CAUSE IRRITATION WHEN APPLYING NEEDLE INSIDE THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305812 ASEM. NEED. 24 X 1 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 0132340

    Patients

    Seq Age Sex Outcome Treatment
    1