BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 22053998 · Received May 20, 2025

    Report

    Report Number
    1911916-2025-00358
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 2, 2025
    Report Date
    May 28, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP A WHITE RESIDUE WAS REPORTED TO BE PRESENT DIRECTLY ON THE NEEDLE. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE SUBMITTED FOR REVIEW BY OUR QUALITY TEAM. THE FIRST IMAGE DEPICTS THE TOP WEB OF THE PACKAGING BLISTER ALONG WITH THE NEEDLE ASSEMBLY AND ITS PLASTIC SHIELD. THE SECOND IMAGE, A MAGNIFIED VIEW, SHOWS THE NEEDLE WITH A WHITE FOREIGN SUBSTANCE. HOWEVER, NO FURTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOGRAPHS ALONE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305127, LOT 4262992. THE REVIEW FOUND NO QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD BE LINKED TO THE REPORTED CONDITION. ADDITIONALLY, THERE WERE NO ASSOCIATED QUALITY NOTIFICATIONS. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER¿S REPORTED OBSERVATION IS CONFIRMED. HOWEVER, DUE TO THE ABSENCE OF A PHYSICAL SAMPLE, IT WAS NOT POSSIBLE TO DETERMINE A PROBABLE ROOT CAUSE.

    Description of Event or Problem · 0

    MATERIAL: 305127 BATCH: 4262992 IT WAS REPORTED BY THE CUSTOMER THAT NOTICED A WHITE RESIDUE DIRECTLY ON THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM CONTACTING YOU TO REPORT AN ISOLATED QUALITY CONCERN REGARDING A BD PRECISIONGLIDE 25G X 1½ TW NEEDLE (REF 305127), LOT NUMBER 4262992, WITH AN EXPIRY DATE OF 20290831. A PATIENT CAME TO MY PHARMACY AFTER USING THIS NEEDLE, WHICH HAD BEEN DISPENSED BY ANOTHER PHARMACY. THE PRIMARY PACKAGING WAS INTACT PRIOR TO USE. DURING THE INJECTION, THE PATIENT EXPERIENCED ABNORMAL RESISTANCE, AND AFTERWARD NOTICED A WHITE RESIDUE DIRECTLY ON THE NEEDLE. THE NEEDLE WAS USED BEFORE THE ISSUE WAS IDENTIFIED. NO ADVERSE EFFECTS HAVE BEEN REPORTED, AND THE PATIENT WAS REASSURED. A PHOTO IS ATTACHED TO THIS EMAIL.

    Description of Event or Problem · 0

    KINDLY PROVIDE THE DATE OF EVENT AROUND (B)(6) 2025

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369296 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4262992 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown