BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE

    MDR report key: 24775976 · Received April 3, 2026

    Report

    Report Number
    3002682307-2026-00032
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 5, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 30GA 1/2IN HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLES RESIST AND SHOW LEAKAGE DURING INJECTION DEAR SUPPLIER, WE (KNF DEPARTMENT) HAVE RECENTLY RECEIVED NEEDLES FROM YOU, INCLUDING ON ORDER (B)(4). ARTICLE: BD MICROLANCE HYPODERMIC NEEDLE 30 G 1/2 0.3 X 13 MM YELLOW SUBCUTANEOUS/INTRADERMAL STERILE LATEX FREE PVC FREE, REF 304000. DOCTORS INDICATE THAT AT LEAST TWO BATCHES ARE NOT GOOD, THE NEEDLES GIVE RESISTANCE WHEN INJECTING PLUS THEY LEAK. HAVE YOU RECEIVED MORE COMPLAINTS ABOUT THIS ITEM AND IS THERE A SOLUTION TO THIS? FOR NOW, THE FOLLOWING LOT NUMBERS ARE INVOLVED: 250608 AND 240512. LOVE TO HEAR ABOUT IT. THANKS IN ADVANCE! WHEN DID THE INCIDENT OCCUR? - DURING USE. ADDITIONAL INFORMATION PROVIDED: COULD YOU PLEASE REACH OUT TO THE CONCERNED PERSON REGARDING LOT#: 250802 TO OBTAIN ADDITIONAL INFORMATION? SPECIFICALLY, WERE THE DEFECTS EXPERIENCED THE SAME AS THOSE ORIGINALLY REPORTED FOR LOTS: 250608 AND 240512? ADDITIONALLY, ARE THE EVENT DATE(S) KNOWN, AND WAS THERE ANY PATIENT IMPACT? RESPONSE RECEIVED ON: (B)(6) 2026 3:25 PM - (B)(6). FOR ALL THE BOXES OF NEEDLES I SENT, THE COMPLAINT IS THE SAME. THE COMPLAINT REPORTED BY THE NEUROLOGIST AND THE PHYSICIAN ASSISTANT WAS: THE NEEDLES LEAKED AT THE TRANSITION TO THE SYRINGE. THERE WAS SIGNIFICANT RESISTANCE TO GETTING THE FLUID THROUGH THE NEEDLE. THERE HAVE BEEN NO INCIDENTS THAT HAD CONSEQUENCES FOR THE PATIENTS. I DO NOT HAVE SPECIFIC DATES AT HAND, BUT IT OCCURRED ON DIFFERENT DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21669 BD NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON, S.A. 250802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown