BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 22166010 · Received June 9, 2025

    Report

    Report Number
    3002682307-2025-00075
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 19, 2025
    Report Date
    September 15, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903022007
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: 302200 AND LOT NUMBER: 220926. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE NEEDLE WAS OBSERVED WITH A BENT CANNULA CROSSING THROUGH THE SHIELD COMPONENT. WE MUST REMARK THAT ONCE THE SHIELD HAS BEEN REMOVED, THE HANDLING OF THE PRODUCT SHOULD BE DONE CAREFULLY TO AVOID ANY RISK OF DAMAGE TO THE CANNULA POINT WHICH WOULD PROVOKE DISCOMFORT AT THE MOMENT OF INJECTION TO THE PATIENT. CARE SHOULD BE TAKEN WHEN WITHDRAWING THE MEDICATION FROM THE VIAL OR RE-ASSEMBLING THE SHIELD (A PRACTICE THAT IS NOT ADVISED). CONSIDERING THE TECHNIQUE USED (FITTING THE PROTECTIVE CAP AFTER NEEDLE USE), WE RECOMMEND USING THE BD ECLIPSE SMARTSLIP NEEDLE, SINCE THIS A SECURITY NEEDLE WITH FOCUS ON PREVENTING NEEDLE STICK AFTER USE. PLEASE CONTACT YOUR LOCAL BD SALES AND MARKETING ORGANIZATION FOR ADDITIONAL ASSISTANCE.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE EU COMPLAINT PROCESSING TEAM REQUEST IS THAT F CODE BE UPDATED TO REFLECT (B)(4).

    Description of Event or Problem · 0

    13-JUNE-2025: PLEASE PROVIDE THE DATE THAT THIS EVENT OCCURRED (DD MM YYYY).19-05-2025. A CONTAMINATED NEEDLE STICK HAS BEEN REPORTED. WERE THERE ANY DIAGNOSTICS PERFORMED AS A RESULT OF THE CONTAMINATED NEEDLE STICK? IF YES, WHAT DIAGNOSTICS WERE PERFORMED? A BLOOD SAMPLE WAS TAKEN RIGHT AFTER THE CONTAMINATION, ANOTHER SAMPLE IS REQUIRED AFTER 4 MONTHS AND AFTER THAT THEY CAN TELL IF THE DENTIST IS CONTAMINATED WITH SOMETHING OR NOT. WAS ANY MEDICAL INTERVENTION REQUIRED? NOT YET, HAVE TO WAIT 4 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES NEEDLE PIERCED THE CAP; HCP FINGERSTICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES CAN VERY EASILY PERFORATE THE CASING ON YOUR PRODUCT. OUR DENTIST GOT STUNG IN HIS FINGER. (B)(6) 2025: WAS THE NEEDLE THROUGH THE SHIELD WITHIN THE PACKAGE BEFORE USE? OR DID THE NEEDLE PIERCE THROUGH THE SHIELD DURING HANDLING/RE-CAPPING? IT PIERCED THROUGH WHEN RECAPPING USED ONLY INSIDE THE ROOT CANAL WITH ANTIBACTERIAL FLUIDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401689 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 220926 00382903022007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown