BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BRAND PRONTO¿ QUICK RELEASE NEEDLE HOLDER

    MDR report key: 24912819 · Received April 17, 2026

    Report

    Report Number
    2243072-2026-00286
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 21, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (NIPRO). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE LOT #:20A10. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: 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 · 0

    IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® BRAND PRONTO¿ QUICK RELEASE NEEDLE HOLDER, AN UNSPECIFIED NUMBER OF UNITS SEPARATED FROM THE NEEDLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520884 BD VACUTAINER® BRAND PRONTO¿ QUICK RELEASE NEEDLE HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 20A10

    Patients

    Seq Age Sex Outcome Treatment
    1