BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 22919495 · Received August 28, 2025

    Report

    Report Number
    3002682307-2025-00105
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 10, 2025
    Report Date
    September 30, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 304000 AND LOT NUMBER 250210. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, IT APPEARED THAT THE CUSTOMER HAD BEEN INJURED BY A BENT CANNULA THAT CROSSED THROUGH THE SHIELD COMPONENT. IT IS IMPORTANT TO EMPHASIZE THAT THE HANDLING OF THE PRODUCT AFTER THE SHIELD HAS BEEN REMOVED¿SUCH AS WITHDRAWING MEDICATION FROM THE VIAL OR ATTEMPTING TO REASSEMBLE THE SHIELD (A PRACTICE THAT SHOULD BE AVOIDED)¿MUST BE DONE WITH GREAT CARE. THIS IS NOT ONLY TO PREVENT THE REPORTED DEFECT BUT ALSO TO AVOID ANY RISK OF DAMAGING THE CANNULA TIP, WHICH COULD CAUSE DISCOMFORT DURING INJECTION FOR THE PATIENT. CONSIDERING YOUR TECHNIQUE (REPLACING THE PROTECTIVE CAP AFTER NEEDLE USE), WE RECOMMEND USING THE BD ECLIPSE¿ SMARTCLIP NEEDLE. THIS IS A SAFETY-ENGINEERED NEEDLE DESIGNED SPECIFICALLY TO PREVENT NEEDLESTICK INJURIES AFTER USE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025. AFTER INJECTING INTO THE ABDOMEN, I WANTED TO PUT A PLASTIC COVER ON THE NEEDLE. THE NEEDLE PIERCED THE PLASTIC COVER AND INJURED MY FINGER. IS THERE AN ALLEGATION OF INJURY TO THE USER OR PATIENT? (PROVIDE DETAILED INFORMATION): YES, PRICKED FINGER. ADDITIONAL KEY INFORMATION WAS THERE A DEATH (YES/NO), SERIOUS INJURY, INCORRECT RESULTS, EXPOSURE TO BLOOD/BODY FLUIDS, SAFETY INCIDENT, OTHER ACTION TAKEN? MY FINGER WAS PRICKED WITH A CONTAMINATED NEEDLE. IN MY OPINION, THE NEEDLE SHOULD NOT PIERCE THE PLASTIC COVER THAT SERVES TO PROTECT IT. I AM NOT MAKING ANY CLAIMS, I JUST WANT TO DRAW ATTENTION TO THIS FACT, IF THIS IS NOT SOMETHING YOU ARE AWARE OF AND IT IS ACCEPTABLE TO YOU. RESPONSE RECEIVED ON (B)(6) 2025. YES, AS A RESULT OF THE INCIDENT, I PRICKED MY FINGER WITH A NEEDLE. HOWEVER, I PERSONALLY ADMINISTERED THE INJECTION INTO MY ABDOMEN MYSELF. THEN, WHILE TRYING TO SECURE THE NEEDLE, THE INCIDENT OCCURRED AND THE NEEDLE PRICKED MY FINGER. CONSIDERING THAT IT IS MY OWN BLOOD AND MY OWN BODY, I DID NOT SEE THE NEED FOR DIAGNOSTIC TESTS OR MEDICAL INTERVENTION. I WILL NOT INFECT MYSELF WITH ANYTHING HOWEVER, I AM REPORTING THIS FACT BECAUSE IN OTHER CASE, IF ONE PERSON GIVES AN INJECTION TO ANOTHER PERSON, THEN SUCH AN INCIDENT, IN MY OPINION, IS DANGEROUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890355 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 250210

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown