BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 17276184 · Received July 6, 2023

    Report

    Report Number
    3002682307-2023-00183
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 14, 2023
    Report Date
    November 8, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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 301500 AND LOT NUMBER 220413. 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 OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR REVIEW. THE RETAINED NEEDLES WERE ASSEMBLED WITH A BD DISCARDIT SYRINGE. LIQUID WAS FOUND TO MOVE NORMALLY THROUGH THE NEEDLES WITH NO SIGNS OF CLOGGING. NEEDLES ARE EVALUATED FOR OCCLUSION AS PART OF THE IN-PROCESS INSPECTIONS AFTER ASSEMBLY. IN CERTAIN CIRCUMSTANCES, THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA, CAUSING THE NEEDLE TO BLOCK DUE TO CRYSTALLIZATION. OCCLUSION IS MOST LIKELY TO OCCUR IF THE DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. 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 DURING ASPIRATION WITH BD MICROLANCE¿ 3 NEEDLE THE NEEDLE WAS CLOGGED AND WOULD NOT DRAW MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: A HEALTHCARE DEPARTMENT REPORTED AN INCIDENT INVOLVING THE USE OF A MICROLANCE 19G NEEDLE, REFERENCE 301500 LOT 220413: "WHEN PREPARING AN IRON INFUSION, THE NEEDLE SUCKS UP ALMOST NOTHING". THE PROBLEM WAS RESOLVED BY CHANGING THE NEEDLE. THERE WERE NO CONSEQUENCES FOR THE PATIENT OR CAREGIVER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED. A HEALTHCARE DEPARTMENT REPORTED AN INCIDENT INVOLVING THE USE OF A MICROLANCE 19G NEEDLE, REFERENCE 301500 LOT 220413: "WHEN PREPARING AN IRON INFUSION, THE NEEDLE SUCKS UP ALMOST NOTHING". THE PROBLEM WAS RESOLVED BY CHANGING THE NEEDLE. THERE WERE NO CONSEQUENCES FOR THE PATIENT OR CAREGIVER. THE NEEDLE CONCERNED IS AVAILABLE FOR ANALYSIS SHOULD YOU WISH TO HAVE IT REUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498985 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220413

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown