BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEEDLE ECLIPSE 25X1 RB

    MDR report key: 19443301 · Received June 1, 2024

    Report

    Report Number
    1920898-2024-00125
    Event Type
    Injury
    Date Received
    June 1, 2024
    Date of Event
    May 2, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382903058372
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CODES UPDATED.

    Description of Event or Problem · 0

    MATERIAL: 305837 LOT:2111820. IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT - CUSTOMER CALLED TO REPORT THAT WHILE SHE WAS VACCINATING A PT. THE NEEDLE BROKE AWAY FROM THE SYRINGE AND GOT STUCK IN A PATIENT, SHE EXPERIENCED A NEEDLE STICK INJURY REF: (B)(4) LOT 2111820, DOE (B)(6) 2024 , THE MEDICATION SPILLED EVERY WHERE AND UNSURE IF THE PT RECEIVED FULL DOSAGE OF THE VACCINATION. SHE COLLECTED BLOOD SAMPLE FROM THE PATIENT TO TEST FOR ANY COMMUNICABLE DISEASE. SHE ALSO ADVISED THAT ANOTHER NURSE HAS EXPERIENCED SUCH INCIDENT WHERE THE NEEDLE DETACHED FROM THE SYRINGE CAUSING A NEEDLE STICK INJURY AS WELL AND SHE THINKS IT IS FROM THE SAME LOT NUMBER. SHE FURTHER NARRATED HOW THIS HAS HAPPENED IN THE PAST, LAST YEAR AND SAME INCIDENT ESPECIALLY WITH THIS VERY TYPE OF NEEDLE BUT IT WAS NOT REPORTED TO BD, ONLY TO THEIR SAFETY DEPARTMENT. ADDITIONAL INFORMATION PROVIDED ON 5/8/2024: 1. I DO NOT HAVE ANY PHOTOS TO PROVIDE AS I DISPOSED OF THE NEEDLE IN THE SHARP'S CONTAINER. 2. THE NEEDLE WAS CONTAMINATED WITH CLIENT'S BLOOD BEFORE I STUCK MYSELF. 3. PATIENT WAS NOT IMPACTED. 4. THIS IS THE THIRD TIME IN THE LAST COUPLE OF MONTHS THAT WE ARE EXPERIENCING THE SAME ISSUE WHEN WE USE THIS NEEDLE. THE PLASTIC APPEARS TO BE WEAK AND BREAKS OFF WHEN THE MEDICINE IS INJECTED. ANOTHER ISSUE IS THAT THE SAFETY GLIDE FALLS OFF EASILY ON THESE NEEDLES (THIS HAPPENS OFTEN). MULTIPLE EMPLOYEES EXPERIENCING THE SAME ISSUE AND ANOTHER EMPLOYEE EXPERIENCED A NEEDLE STICK INJURY AFTER USING THIS BRAND NEEDLE. ADDITIONAL INFORMATION PROVIDED ON 5/30/2024/ 1) WAS THE ADDITIONAL NEEDLE STICK THE RESULT OF THE SAFETY MECHANISM DETACHING? 2) WAS THE ADDITIONAL NEEDLE STICK CLEAN OR CONTAMINATED? 1. YES. 2. NEEDLE STICK WAS CONTAMINATED WITH PATIENT'S BLOOD.

    Description of Event or Problem · 0

    IMDRF CODES MUST BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968026 BD NEEDLE ECLIPSE 25X1 RB ECLIPSE NEEDLE FMI BD MEDICAL - DIABETES CARE 2111820 00382903058372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other