BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE SMARTSLIP

    MDR report key: 21173498 · Received January 16, 2025

    Report

    Report Number
    3002682307-2025-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 27, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    50382903058865
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305886 AND BATCH NUMBER 2101008. 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 REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE NEEDLES WERE ASSEMBLED WITH A BD DISCARDIT 2ML SYRINGE; HOWEVER, NO SIGNS OF DEFECTIVE CONNECTION WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO REPRODUCE THE REPORTED ISSUE AND AN EXACT CAUSE COULD NOT BE DETERMINED. ENGAGEMENT FORCE IS MEASURED DURING MANUFACTURE AS PART OF THE IN-PROCESS INSPECTIONS AND FINAL TESTING PRIOR TO RELEASE. SMARTSLIP TECHNOLOGY HAS BEEN INTRODUCED TO ENSURE THAT A SECURE CONNECTION IS MADE WITH LUER SLIP SYRINGES. WE RECOMMEND FOLLOWING THE INSTRUCTIONS FOR USE, WHICH ARE UNIQUE IN DIRECTING THE USER TO PUSH FIRMLY WHEN ATTACHING THE NEEDLE TO THE SYRINGE AND TO BE SURE THAT THE CLIP IS ACTIVATED. BD NEEDLES ARE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS AND COMPLIES WITH ISO (INTERNATIONAL ORGANIZATION FOR STANDARDIZATION) STANDARD. 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 NEEDLE 23X1-1/4 ECLIPSE SMARTSLIP LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WRITER USED A 3ML SYRINGE (LOT:3305235) AN 23G IM NEEDLE (LOT: 2101008) TO GIVE A DOSE OF HEPAGAM. DURING ADMINISTRATION OF THE BLOOD PRODUCT, WRITER NOTICED SIGNIFICANT LEAKING FROM THE CONNECTION PORT OF THE SYRINGE. DATE OF INCIDENT: (B)(6) 2024 SITE NAME/LOCATION: LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON -- INCONVENIENT. WHO WAS AFFECTED? PATIENT FREQUENCY OF PROBLEM: FIRST TIME INVASIVE PROCEDURE? NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892271 BD NEEDLE ECLIPSE SMARTSLIP NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 2101008 50382903058865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown