BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLE

    MDR report key: 19824512 · Received July 25, 2024

    Report

    Report Number
    3002682307-2024-00150
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    April 18, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903031290
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 230201 AND 231005. 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, FOUR (4) PICTURES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THREE (3) PICTURES, A MEDICATION BOTTLE WITH A GREY PARTICLE WAS OBSERVED. THE OTHER PICTURE SHOWED THE OUTSIDE OF THE NEEDLE BLISTER PACKAGE. AN ADDITIONAL FORTY (40) RETAINED SAMPLES, TWENTY (20) OF EACH LOT PROVIDED, WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE TESTED WITH A LABORATORY VIAL (PLASTIC STOPPER) AND NO DIFFICULTIES WERE IDENTIFIED. AFTER TESTING, THE SAMPLES WERE MICROSCOPICALLY EXAMINED AND NO PARTICLES FROM VIAL STOPPER FRAGMENTATION WERE FOUND, AND ALL NEEDLE BEVELS WERE WELL FORMED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS CANNOT BE DETERMINED. WITH THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT THE CORING EFFECT 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. AS THIS NEEDLE HAS A BLUNT BEVEL, IT SHOULD PENETRATE THE STOPPER AT A 90-DEGREE ANGLE TO MINIMIZE THE RISK OF CORING. IF THE AFFECTED PHYSICAL SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO PERFORM A THOROUGH ANALYSIS. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLE; NEEDLE CORES THE RUBBER STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: 3 CASES OF DISPLACEMENT OF RUBBER PARTICLES INSIDE THE DRUG CONTAINER. THEY WERE OBSERVED DURING RECONSTITUTION AND WERE NOT ADMINISTERED. THE DRUGS WERE ALL THREE DIFFERENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354262 BD CONVENTIONAL NEEDLE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 231005 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown