BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® BLUNT FILL NEEDLE

    MDR report key: 17708921 · Received September 8, 2023

    Report

    Report Number
    3002682307-2023-00265
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 22, 2023
    Report Date
    February 7, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 230108. 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. ALTHOUGH SAMPLES WERE SHIPPED FOR INVESTIGATION, UNFORTUNATELY, THE SAMPLES COULD NOT BE FOUND UPON DELIVERY. IF THE SAMPLES ARE LOCATED, A REVISED INVESTIGATION CAN BE PERFORMED. WE APOLOGIZE FOR THE INCONVENIENCE. AT THIS TIME, TWENTY (20) RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION. THE RETAINED SAMPLES WERE TESTED WITH A LABORATORY VIAL (PLASTIC STOPPER) AND NO DIFFICULTIES WERE IDENTIFIED. THE RETAINED SAMPLES WERE MICROSCOPICALLY EXAMINED; NO PARTICLES FROM VIAL STOPPER FRAGMENTATION WERE FOUND AND ALL BEVELS WERE WELL FORMED. A DEFECT RELATED TO THE CANNULA MANUFACTURING PROCESS COULD NOT BE DETERMINED AT THIS TIME. 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. NEEDLES WITH SHORT BEVELS, LIKE MATERIAL 303129, SHOULD PENETRATE THE VIAL STOPPER AT A NINETY-DEGREE ANGLE TO MINIMIZE THE RISK OF CORING. 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

    H3. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD® BLUNT FILL NEEDLE WAS CORING DURING USE. THE FOLLOWING WAS TRANSLATED FROM FRENCH TO ENGLISH: WHEN PREPARING PREMEDICATIONS IN THE TREATMENT ROOM, THE NURSE NOTICES A DEPOSIT IN THE SYRINGE AFTER PIERCING THE DRUG MEMBRANE WITH THE NEEDLE. IN FACT, THE NAKED EYE CAN CLEARLY SEE A "PARTICLE" IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242496 BD® BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown