BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 22126496 · Received June 2, 2025

    Report

    Report Number
    1213809-2025-00364
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    March 24, 2025
    Report Date
    May 14, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NEITHER A LOT NUMBER NOR A SAMPLE WAS AVAILABLE FOR THIS INCIDENT, A COMPLETE INVESTIGATION COULD NOT BE CONFIRMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309646. BATCH # UNKNOWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT CODE: 309646. PRODUCT DESCRIPTION: SYRINGE HYPO 5CC L/L BX/125 P36. LOT/SERIAL #: 287044. EXPIRY DATE: UNKNOWN. PROBLEM INFORMATION: PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: (B)(6) 2025 CONCERN DESCRIPTION: CRACKS ON SYRINGE BARREL, NOTICED BY NURSING STAFF AND PHARMACY STAFF AFTER SYRINGE WAS FILLED. POSSIBLE STERILITY CONCERNS AS CRACK COULD ALLOW OUTSIDE AIR TO CONTAMINATE DRUG SOLUTION WITHIN SYRINGE. OCCURRENCES: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619366 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown