BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1 RB

    MDR report key: 20999843 · Received December 23, 2024

    Report

    Report Number
    1911916-2024-00944
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 2, 2024
    Report Date
    January 12, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE NEEDLES SEEMED OCCLUDED. TO AID IN THE INVESTIGATION, THIRTY-FIVE SAMPLES IN SEALED PACKAGING BLISTERS WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION; ALL THE SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305125, LOT 4060114. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL#: 305125 BATCH#: 4060114. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE HAD 3 IM NEEDLES IN THE LAST TWO DAYS THAT WERE DEFECTIVE. IT SEEMS LIKE THE NEEDLES WERE OCCLUDED. I DON¿T KNOW WHAT THE LOT NUMBER WAS FOR YESTERDAY, AS I WAS JUST INFORMED OF THIS. HOWEVER, THE NEEDLE TODAY WAS FROM LOT NUMBER: 4060014. THESE ARE THE PRECISIONGLIDE NEEDLES 25G X 1¿.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. HARM TO PATIENT HCP: WAS THERE ANY HARM TO THE PATIENT OR HEALTHCARE PROFESSIONAL (HCP)? PATIENTS HAD TO BE POKED TWICE TO ADMINISTER THE IMMUNIZATION DELAY IN TREATMENT: DID THE EVENT CAUSE ANY DELAY IN TREATMENT? TREATMENT WAS DELAYED BY A FEW MINUTES IN THE PATIENTS WHO WERE POKED BY THE DEFECTIVE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91363 NEEDLE 25X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4060114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown