BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 19837655 · Received July 26, 2024

    Report

    Report Number
    3002682307-2024-00151
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903032624
    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

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 231101 (OBTAINED FROM RETURNED SAMPLE). 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) UNOPENED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLE WAS VISUALLY EXAMINED AND NO DEFECTS WERE OBSERVED IN THE CANNULA POINT WHICH COULD RESULT IN CORING. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. WE WOULD LIKE TO INFORM YOU THAT NEW MATERIAL 303262 HAS A REGULAR BEVEL IN COMPARISON TO MATERIAL 304322 WHICH HAD A SHORT BEVEL. THIS MEANS THAT THE WAY THE NEEDLE PUNCTURES THE VIAL CHANGES. FOR MATERIAL 303262, THE ANGLE OF PENETRATION FOR THE VIAL SHOULD BE BETWEEN 45 TO 60 DEGREES. 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. PLEASE FIND ATTACHED THE JOB AID ¿BD-110636 HOW TO REDUCE CORING WITH A SHARP NEEDLE¿ WHICH EXPLAINS HOW THE HANDLING SHOULD BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES CORE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: SINCE THE CHANGE OF THE 303235 CANULA REFERENCE IN JULY 2023, THE NEW CANULAS HAVE A " CORING " EFFECT ON THE LIDS OF PRODUCTS QUITE FREQUENTLY, NOTABLY WITH BRAUN ECOFLAC NACL0.9% VIALS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734905 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 231101 00382903032624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown