BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X1-1/2 RB

    MDR report key: 20060865 · Received August 25, 2024

    Report

    Report Number
    1920898-2024-00137
    Event Type
    Malfunction
    Date Received
    August 25, 2024
    Date of Event
    August 7, 2024
    Report Date
    January 10, 2025
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382903058389
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 5 UNUSED NEEDLES WERE RECEIVED AND TESTED BY OUR QUALITY TEAM. THE SAMPLES WERE TESTED BY ASPIRATING PLUNGER WHILE ATTACHED TO SYRINGE AND INJECTING WITH BOTH AIR AND WATER. THE NEEDLES PRESENTED NO ISSUES AND THE COMPLAINT OF CLOGGED NEEDLES COULD NOT BE VERIFIED. THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT MORE INFORMATION LIKE THE USED NEEDLES. THE PRODUCTION HISTORY WAS ANALYZED AND THERE WERE NO ISSUES FOUND DURING QUALITY INSPECTIONS THAT WOULD LEAD TO THIS ISSUE.

    Description of Event or Problem · 0

    MATERIAL: 305838 BATCH#: 2355492. IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1-1/2 RB NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. VERBATIM: EVENT DATE: 8-7-2024 EVENT LOCATION: XXXX EVENT DESCRIPTION: ¿WHILE PA WAS COMPLETING A JOINT INJECTION ON A PATIENT, THE NEEDLE WOULDN'T ALLOW THE MEDICINE TO INJECT. SHE CHANGED OUT NEEDLES TO ANOTHER NEW ONE AND IT DID THE SAME THING AGAIN. NEEDLE 25 G X 1 1/2" BD ECLIPSE NEEDLE LOT 2355492 EXP 12/31/2027¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY TO MY KNOWLEDGE. PRODUCT NAME: ITM-1150133 - NEEDLE SAFETY 25G X 1.5 PRODUCT REF: 305838 LOT NUMBER: 2355492 BD CUSTOMER ACCOUNT NUMBER: (B)(6). ACTUAL PRODUCT INVOLVED IS NOT YET AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    SAMPLES RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230775 BD NEEDLE ECLIPSE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL - DIABETES CARE 2355492 00382903058389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown