BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION

    MDR report key: 8325833 · Received February 11, 2019

    Report

    Report Number
    3002682307-2019-00136
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Date of Event
    January 25, 2019
    Report Date
    March 11, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903058921
    PMA / PMN Number
    K100209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. BD HAS BEEN PROVIDED WITH ONE OPENED SAMPLE OF LOT 1810001. NEEDLE LOOKS LIKE IT WAS USED SINCE NO SHIELD WAS RECEIVED AND SAFETY SHIELD WAS ACTIVATED. HOWEVER, SNAP CLIP WAS NOT ACTIVATED (WHICH IS NECESSARY TO ASSURE A CORRECT ASSEMBLY). RETURNED SAMPLE WAS ASSEMBLED INTO A BD LUER LOCK SYRINGE (PLASTIPAK) FOLLOWING INSTRUCTIONS AND NO ISSUES WERE OBSERVED OR EXPERIENCED: SNAP CLIP WAS ACTIVATED CORRECTLY. BASED ON ABOVE RESULTS AND AVAILABLE INFORMATION, NO ISSUES HAVE BEEN DETECTED IN RETURNED SAMPLE AND CONSIDERING THE DHR, BD COULD NOT IDENTIFY ANY POSSIBLE ROOT CAUSE RELATED TO NEEDLE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION HAS A LOOSE CONNECTION BECAUSE OF THE DIFFICULTY IN ASSEMBLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION HAS A LOOSE CONNECTION BECAUSE OF THE DIFFICULTY IN ASSEMBLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117913 BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1810001 00382903058921

    Patients

    Seq Age Sex Outcome Treatment
    1 Other