BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 22456877 · Received July 9, 2025

    Report

    Report Number
    9614033-2025-00070
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    May 16, 2025
    Report Date
    February 4, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903046560
    PMA / PMN Number
    NA
    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

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO PHOTOS AND A PHYSICAL SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. IN ONE OF THE PHOTOGRAPHS, THERE IS A RED CIRCLE NEAR THE SCALE MARKING TO HIGHLIGHT THE REPORTED FOREIGN MATERIAL. DURING THE DECONTAMINATION PROCESS OF THE PHYSICAL SAMPLE RECEIVED, THE FOREIGN MATERIAL WAS LOST, MAKING ITS PHYSIO CHEMICAL ANALYSIS THROUGH TECHNIQUES SUCH AS FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) IMPOSSIBLE. IN THE ABSENCE OF PHYSICAL EVIDENCE, IT WAS NOT POSSIBLE TO IDENTIFY OR CONFIRM THE NATURE OF THE CONTAMINANT. HOWEVER, THE APPEARANCE OBSERVED IN THE PHOTOGRAPH TAKEN PRIOR TO DECONTAMINATION SHOWS SIMILARITY TO ADHESIVE TAPE WHICH CAN BE CONSIDERED A POTENTIAL FAILURE MODE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, A POSSIBLE ROOT CAUSE FOR TAPE CAN BE TRACED TO MANUFACTURING. ACTIONS HAVE BEEN PUT IN PLACE IN RESPONSE TO THIS REPORT. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 304656, LOT#: 4193536. RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER(S): (B)(4), PRODUCT SKU: 153245, PRODUCT LOT NUMBER: 4193536, COMPLAINT DETAILS: ¿ON (B)(6) CUSTOMER STATED THAT HE RECEIVED CONTAMINATED PACK. ADDITIONAL INFORMATION PROVIDED: IT WAS REPORTED THAT ON (B)(6) 2025 THAT THERE WAS "CONTAMINANT" IDENTIFIED "WITHIN THE GROOVES OF THE PLUNGER INSIDE THE SYRINGE". THE CUSTOMER REPORTED THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT. THE CUSTOMER REPORTED THE PROCEDURE WAS COMPLETED UTILIZING A NEW PACK. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523141 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4193536 00382903046560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown