BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X1-1/2 RB

    MDR report key: 21404810 · Received February 18, 2025

    Report

    Report Number
    2243072-2025-00106
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 29, 2025
    Report Date
    May 14, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903058389
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 116 UNUSED SAMPLES OF MIXED LOTS (BATCH # 2355494, 2306052, 2210218, 2210220) WERE RECEIVED AND ANALYZED BY OUR QUALITY TEAM WITH THE CUSTOMER'S COMPLAINT OF NEEDLE OCCLUSION/ NEEDLE BLOCKAGE. ALL NEEDLES WERE TESTED BY DRAWING AND INJECTING AIR THEN WATER AND NO NEEDLES SHOWED ANY ISSUES. THERE WERE NO CLOGS OR BLOCKAGES NOTICED. THE COMPLAINT COULD NOT BE VERIFIED DUE TO THE NEEDLES FUNCTIONING AS USUAL AND THE ROOT CAUSE REMAINS UNKNOWN. THE PRODUCTION HISTORY WAS ANALYZED AND THERE WERE NO ISSUES FOUND DURING QUALITY INSPECTIONS THAT WOULD LEAD TO THIS ISSUE.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. D.4. OTHER LOT NUMBERS INCLUDE 2355494, 2306052, AND 2210218. OTHER EXPIRATION DATES INCLUDE 2027-12-31 AND 2027-10-31. E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATES ARE 2022-12-21, 2022-11-02 AND 2022-07-29.

    Description of Event or Problem · 0

    SAMPLES RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#: 305838, BATCH#: 2355494, 2306052, 2210218, 2210220. IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1-1/2 RB WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM: 305838, LOT: 2355494. PO: (B)(4). ISSUE: AFTER DRAWING MEDICINE CAN ONLY PUSH SYRINGE HALFWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2540704 BD NEEDLE ECLIPSE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 2210220 00382903058389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown