BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE 3 CANNULAS 18 G

    MDR report key: 17753115 · Received September 15, 2023

    Report

    Report Number
    3002682307-2023-00277
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 17, 2023
    Report Date
    December 11, 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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 230505. 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 RETAINED SAMPLES WERE VISUALLY EXAMINED AND NO SIGNS OF DEFECT WERE OBSERVED. THE SAMPLES WERE THEN USED TO PUNCTURE A TEST VIAL AND THEN RE-EXAMINED MICROSCOPICALLY. NO SIGNS OF DEFECT WERE IDENTIFIED. WE WOULD LIKE TO INFORM YOU THAT MATERIAL 303262 HAS BEEN CREATED WITH A REGULAR CANNULA BEVEL IN COMPARISON TO MATERIAL 304622 WHICH HAD A SHORT BEVEL. THIS BEVEL DIFFERENCE CHANGES THE WAY THE NEEDLE SHOULD PUNCTURE THE VIAL. MATERIAL 303262 SHOULD PUNCTURE THE VIAL FROM 45-60 DEGREES TO MINIMIZE THE RISK OF NEEDLE VIAL CORING AND THEREFORE, CLOGGING. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE IT IS UNLIKELY THAT THIS INCIDENT RESULT FROM POOR OR INSUFFICIENT DE-BURRING OF 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. SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    H3: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE 3 CANNULAS 18 G FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: SHORT DESCRIPTION: SYRINGE CLOGGING. WHEN DID THE INCIDENT OCCUR? DURING USE. DETAILED INCIDENT DESCRIPTION: WHEN A NEEDLE IS USED TO PREPARE INFUSIONS, IT BECOMES BLOCKED BY CORING THE PUNCTURE SITE FOR THE SOLUTIONS. IT IS THEN VERY DIFFICULT TO EMPTY THE SYRINGE OF ITS CONTENTS. YOU CAN SEE THE PIECE OF RUBBER BLOCKING THE NEEDLE'S LUMEN. CLINICAL CONSEQUENCES: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269468 BD MICROLANCE 3 CANNULAS 18 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230505

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown