BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 21161419 · Received January 15, 2025

    Report

    Report Number
    1024879-2025-00015
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    April 6, 2024
    Report Date
    January 14, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K212724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A REPLACEMENT TO THE ORIGINAL SUBMISSION UNDER MFR REPORT # 2243072-2024-01268 ON 30DEC2024 IN ORDER TO FILE AGAINST THE CORRECT SITE REGISTRATION NUMBER. D2B. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: FPA. 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 367365 OR 367364. 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® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE SAFETY FEATURE WOULD NOT ENGAGE AND WHEN PLACING IN SHARPS CONTAINER IT STRUCK THE END-USER'S RIGHT THUMB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CURRENTLY USE THE VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET, WHICH STAFF ARE UNFORTUNATELY STILL HAVING NEEDLESTICK INJURIES WITH". "USED TWO-HANDED (GREEN 21G) BUTTERFLY NEEDLE TO STRAIGHT STICK PT. SAFETY WOULD NOT ENGAGE. PUT EXPOSED NEEDLE IN SHARPS CONTAINER AND WHEN ATTEMPTING TO DEPOSIT NEEDLE IT STUCK RIGHT THUMB". "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
    1300265 UNSPECIFIED BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON & CO., (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other