BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20337221 · Received September 30, 2024

    Report

    Report Number
    3002682307-2024-00200
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 5, 2024
    Report Date
    November 5, 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
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 240504. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION. THE NEEDLES WERE EXAMINED AND CANNULA BEVEL SHOWS NO ISSUE AND NO SIGNS OF CORING EFFECT WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO REPRODUCE THE REPORTED ISSUE AND AN EXACT CAUSE COULD NOT BE DETERMINED. 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 COULD HAVE HAD AN IMPLICATION IN THE REPORTED EVENT. THE NEEDLE SHOULD PENETRATE THE VIAL STOPPER AT A NINETY-DEGREE ANGLE TO MINIMIZE THE RISK OF CATCHING THE INTERNAL WALL OF THE VIAL STOPPER. 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

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES NEEDLE CORED THE RUBBER STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DESCRIBE THE EVENT IN A FACTUAL WAY: DURING THE RECONSTITUTION OF AN ANTIBIOTIC, DISCOVERY IN THE BOTTLE OF A RUBBER ¿SPRUE¿ CAUSED BY THE RED TROCARD NEEDLE REF 303129 (WHICH WE HAVE IN ENDOWMENT) WHILE CROSSING THE RUBBER LID. TOO LARGE A GAUGE FOR THE TROCARD? REAL CONSEQUENCES FOR THE PATIENT, TEAM... (IF NO CONSEQUENCE, NOTE ¿NO CONSEQUENCE¿): NO CONSEQUENCE IMMEDIATE ACTION TAKEN: RECONSTITUTION OF ANOTHER BOTTLE COLLEAGUES WARNED OF RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594657 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240504 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown