BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION

    MDR report key: 8187369 · Received December 20, 2018

    Report

    Report Number
    3002682307-2018-00347
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 21, 2018
    Report Date
    January 21, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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 SUMMARY: 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. NEEDLES WERE PACKED IN MACHINE 2107 (APRIL 22-24TH, 2018) DURING WHICH 45 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLES (#8103875) WERE ASSEMBLED NEEDLES IN MACHINE 4414 (APRIL 16-18TH, 2018) DURING WHICH 407 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. RESEARCH HAS NOT FOUND NO ISSUES OR ABNORMALITIES DURING MANUFACTURING OF INJECTED HUB BATCHES #8065776, #8058763, #8051579, #7156009, #8099589, #8096846 AND #8107694 (MOLD MACHINE 3567 ¿ FROM FEBRUARY TO JUNE 2018). 1 QN WAS NOTED IN INJECTED HUB BATCH #8043991 RELATED TO CLOGGED LUMEN (#10577) BUT THIS DEFECT WOULD NOT AFFECT THE REPORTED ISSUE. CANNULA BATCHES #8080601 AND #8017971. NO SAMPLES NEITHER PICTURES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION THERE WAS AN ISSUE WITH AFTER INJECTION THE NEEDLE REMAINS BEHIND AND COMES OFF OF SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION THERE WAS AN ISSUE WITH AFTER INJECTION THE NEEDLE REMAINS BEHIND AND COMES OFF OF SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026712 BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1804009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other