BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 17800132 · Received September 22, 2023

    Report

    Report Number
    3002682307-2023-00290
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 29, 2023
    Report Date
    April 17, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBERS 230507 AND 230501. 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 WITHIN SPECIFICATIONS. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE NEEDLE WAS FOUND PARTIALLY CLOGGED WITH VIAL MATERIAL. TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FOR ADDITIONAL EVALUATION. THE RETAINED SAMPLES WERE VISUALLY EXAMINED AND THEN USED TO PUNCTURE A TEST VIAL BEFORE RE-EXAMINATION UNDER MICROSCOPE. THE RETAINED SAMPLES DID NOT REVEAL ANY SIGNS OF DEFECT. BD HAS INVESTIGATED THIS TYPE OF ISSUE IN DETAIL IN THE PAST, PERFORMING DIFFERENT ANALYSES FOR MATERIAL CHARACTERIZATION AND CONDUCTING SIMULATED STUDIES ON THE EVENT THROUGH MULTIPLE TYPES OF CONTAINERS AND NEEDLES. THE CLOGGED COMPONENT IN THESE SCENARIOS IS COMMONLY GENERATED WHEN NEEDLES ARE USED TO ACCESS THE SEPTUM OF RIGID PLASTIC CONTAINERS OF SALINE OR OTHER MEDICATION SOLUTIONS DESIGNED TO HAVE A DOUBLE SEPTUM, THE FIRST BEING A NORMAL RUBBER CLOSURE AND THE SECOND A THICK POLYETHYLENE SEPTUM. BD MICROLANCE NEEDLES ARE INTENDED TO PENETRATE THE SKIN AND RUBBER VIAL CLOSURES. THEY ARE NOT DESIGNED TO PENETRATE THICK POLYETHYLENE MEMBRANES. DEDICATED DEVICES ARE AVAILABLE FROM THE SUPPLIER OF THE RIGID PLASTIC CONTAINERS. BD RECOMMENDS CONTACTING THE MANUFACTURER OF THE CONTAINER FOR A DETAILED LIST OF THESE ACCESSORIES. WE WOULD ALSO LIKE TO INFORM YOU THAT MATERIAL 303262 HAS BEEN CREATED WITH A REGULAR CANNULA BEVEL IN CONTRAST TO MATERIAL 304622 WHICH HAD A SHORT BEVEL; THIS MEANS THE WAY THE NEEDLE PUNCTURES THE VIAL MUST CHANGE. MATERIAL 303262 SHOULD PENETRATE THE VIAL AT A 45¿60-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

    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 5 BD MICROLANCE¿ 3 NEEDLES WERE CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "SHORT DESCRIPTION. WHEN PREPARING A MEDICINE IMPOSSIBLE TO TAKE THE NEEDLE SEEMS CLOGGED. WHEN DID THE INCIDENT OCCUR? DURING USE. DETAILED INCIDENT DESCRIPTION. THE IDE MUST PREPARE AN INFUSION AND MUST USE A PINK TROCAR, IMPOSSIBLE TO TAKE, SEEMS BLOCKED. SHE CHANGES HER TROCARD 5 TIMES, SAME PROBLEM. INTERNAL COMMENTS. NO CONSEQUENCES FOR THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241966 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230507

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown