BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 21093039 · Received January 7, 2025

    Report

    Report Number
    1024879-2024-01348
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    October 31, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE THE SPECIFIC MATERIAL USED FOR THIS INCIDENT. PER THE END-USER, THE MATERIAL WAS EITHER 368608 OR 368607. BOTH OF THESE PRODUCTS ARE MANUFACTURED IN OUR SUMTER, SC FACILITY. THEREFORE, BECTON, DICKINSON & CO., (BD), SUMTER, SC HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE BECTON, DICKINSON & CO., (BD), SUMTER, SC FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D4. UNIQUE IDENTIFIER (UDI) #: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC MATERIAL AND LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED WHILE USING AN UNSPECIFIED BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, A NEEDLESTICK INJURY OCCURRED POST-USE AFTER FAILURE TO ENGAGE SAFETY FEATURE AND NEEDLE POKED WRIST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER RESPONDED STATING THAT SHE WAS ONLY ABLE TO OBTAIN "THE DATE OF INCIDENT AND A QUOTE FROM THE EMPLOYEE ON THE INCIDENT REPORT" AS FOLLOWS: (B)(6) 2024-FINISHED BLOOD DRAW BUT DID NOT ENGAGE SAFETY FEATURE AND IT POKED HER WRIST; THERE ARE NO PICTURES. ALL RESULTED IN BODY FLUID EXPOSURE WITH BLOOD DRAW FOLLOW UP FOR 6 MONTHS." THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011156 UNSPECIFIED BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON, DICKINSON & CO., (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other