BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® MICROLANCE¿ 3 HYPODERMIC NEEDLE, 18G

    MDR report key: 17873694 · Received October 4, 2023

    Report

    Report Number
    3002682307-2023-00300
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 22, 2023
    Report Date
    November 20, 2023
    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

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 230408. 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 REVIEW. THE RETAINED SAMPLES WERE VISUALLY EXAMINED AND NO DEFECTS WERE IDENTIFIED. THEY WERE THEN USED TO PUNCTURE A TEST VIAL AND REEXAMINED MICROSCOPICALLY; HOWEVER, NO DEFECTS WERE IDENTIFIED. BASED ON THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT AN ISSUE OF CORING NEEDLE WHICH THEN RESULTED IN A CLOGGED NEEDLE OCCURRED. MATERIAL 303262 HAS BEEN CREATED WITH A REGULAR BEVEL COMPARED TO MATERIAL 304622 WHICH HAD A SHORT BEVEL. MATERIAL 303262 SHOULD HAVE AN ANGLE OF PENETRATION FROM 45-60 DEGREES TO MINIMIZE THE RISK OF CORING. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT THIS INCIDENT RESULTED FROM A DEFECT IN THE CANNULA DURING MANUFACTURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD® MICROLANCE¿ 3 HYPODERMIC NEEDLE, 18G WAS BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE TROCARS (PINK NEEDLE 18G X 40MM) ARE BLOCKED. INDEED, WHEN WE WANT TO SUCK UP A LIQUID, THERE IS A STRONG PRESSURE. WHEN WE WANT TO INJECT, THERE IS ALSO PRESSURE AND THEN A SMALL PIECE COMES OUT OF THE TROCAR AND IT WORKS AGAIN. WE ARE VERY CURIOUS ABOUT THE PIECE THAT COMES OFF THE TROCAR: AN UNIDENTIFIED PARTICLE THAT ESCAPES FROM THE TROCAR AND MIXES WITH OUR INJECTABLE PREPARATIONS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION. THE TROCARS (PINK NEEDLE 18G X 40MM) ARE BLOCKED. INDEED, WHEN WE WANT TO SUCK UP A LIQUID, THERE IS A STRONG PRESSURE. THE TROCARS (PINK NEEDLE 18G X 40MM) ARE BLOCKED. INDEED, WHEN WE WANT TO SUCK UP A LIQUID, THERE IS A STRONG PRESSURE. WHEN WE WANT TO INJECT, THERE IS ALSO PRESSURE AND THEN A SMALL PIECE COMES OUT OF THE TROCAR AND IT WORKS AGAIN. WE ARE VERY CURIOUS ABOUT THE PIECE THAT COMES OFF THE TROCAR: AN UNIDENTIFIED PARTICLE THAT ESCAPES FROM THE TROCAR AND MIXES WITH OUR INJECTABLE PREPARATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344667 BD® MICROLANCE¿ 3 HYPODERMIC NEEDLE, 18G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown