BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 17969575 · Received October 19, 2023

    Report

    Report Number
    3002682307-2023-00312
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    August 24, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 221206. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE AND THE AFFECTED PHYSICAL SAMPLE WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, A BLUNT NEEDLE AND A VIAL WAS OBSERVED. A BLACK PARTICLE WAS OBSERVED FLOATING IN THE LIQUID, WHICH APPEARED TO BE THE VIAL MATERIAL. THE NEEDLE WAS REMOVED AND MICROSCOPICALLY EXAMINED; HOWEVER, NO IRREGULARITIES WERE FOUND IN THE CANNULA BEVEL TO IDENTIFY A MANUFACTURING RELATED CAUSE FOR THIS INCIDENT. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. IT IS POSSIBLE THAT THE STOPPER CONDITIONS (ASK YOUR SUPPLIER FOR MATERIAL CHANGES AS WELL AS RECOMMENDATIONS OF STORAGE IN CASE HUMIDITY AND/OR TEMPERATURE AFFECTS THE FRAGMENTATION OF THE RUBBER) AND THE HANDLING OF THE PRODUCT HAD A ROLE IN THE REPORTED INCIDENT. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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 · 0

    IT WAS REPORTED THAT PIECES OF THE RUBBER VIAL STOPPER WERE CORED BY AND STUCK ONTO THE BD¿ BLUNT FILL NEEDLE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "RUBBER PIECES OF MEDICATION AMPULE STICK TO NEEDLE (ONLY LOT 221206 AFFECTED). WHILE PREPARING MEDICATION, NEEDLE (BLUNT FILL, 303129) WAS INSERTED INTO MEDICATION AMPULE (ACCORDING TO IFU- PERPENDICULAR) AND RUBBER PIECES OF THE AMPULE STICK TO THE NEEDLE. 1 SAMPLE AVAILABLE. HAPPENED ON SEVERAL OCCASIONS WITH PRODUCTS FROM LOT# 221206, CUSTOMER TRIED OTHER LOT NUMBERS, WHICH WORKED FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749746 BD¿ BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 221206

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown