BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE

    MDR report key: 19977385 · Received August 13, 2024

    Report

    Report Number
    3002682307-2024-00160
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 19, 2024
    Report Date
    December 24, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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. E1. ADDRESS EXCEEDS CHARACTER LIMIT: (B)(6).

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 240108. 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. ALTHOUGH A SAMPLE SHIPMENT WAS ORIGINALLY INITIATED; UNFORTUNATELY, THE SHIPMENT APPEARS TO HAVE BEEN LOST IN TRANSIT. AT THIS TIME, SAMPLES WERE UNAVAILABLE FOR THE INVESTIGATION OF THIS EVENT. TWENTY (20) RETAINED SAMPLES OF THE REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER REVIEW. THE RETAINED NEEDLE SAMPLES WERE ASSEMBLED WITH BD EMERALD SYRINGES BY FOLLOWING THE INSTRUCTIONS FOR USE, THE NEEDLE HUB WAS POSITIONED ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE SAMPLES DISPLAYED ANY SIGN OF DEFECT; ALL THE NEEDLES FIT THE SYRINGE TIPS PROPERLY WITHOUT LEAKAGE. BASED ON THE INVESTIGATION RESULTS, A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED. PER THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT A DEFECTIVE HUB CONNECTION ISSUE TOOK PLACE. BASED ON OUR EXPERIENCE, THIS ISSUE COULD HAVE OCCURRED DUE TO DEFECTIVE SYRINGE LUER DIMENSIONS OR ANY DAMAGE IN THE SYRINGE TIP. IT COULD ALSO BE RELATED TO THE HANDLING OF THE PRODUCT, IF AN INSUFFICIENT ADJUSTMENT WAS MADE BETWEEN THE DEVICES BY THE END USER. 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 BD MICROLANCE LEAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE DON'T UNDERSTAND WHY IT STICKS TO THE SKIN AND THE PRODUCT LEAKS FROM THE SYRINGE. PRODUCT IS LEAKING FROM THE SYRINGE. HAVE YOU HAD ANY PROBLEMS WITH THESE BATCHES LATELY? 26 JUL. HAS THERE BEEN AN IMPACT ON THE PATIENT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE IN TREATMENT NECESSARY)? NO. DID THE MALFUNCTION CAUSE A NEEDLESTICK INJURY TO THE HEALTHCARE STAFF OR THE PATIENT? NO.

    Description of Event or Problem · 0

    30-JUL-2024. BD QUESTION: AS IT WAS MENTIONED IN THE COMPLAINT E-MAIL AS " WE DON'T UNDERSTAND WHY IT STICKS TO THE SKIN". COULD YOU PLEASE CONFIRM WHETHER THIS MEANS TO THE NEEDLE STICK INJURY? CUSTOMER ANSWER: "NO INJURY, JUST A SENSATION OF STICKINESS ON THE SKIN AND LEAKAGE OF THE PRODUCT FROM THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176451 BD MICROLANCE NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240108 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown