BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 19534310 · Received June 13, 2024

    Report

    Report Number
    1213809-2024-00372
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    April 19, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    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

    SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MATERIAL# 302995, BATCH# 4061797. IT WAS REPORTED BY CUSTOMER THAT SYRINGE BARREL CRACKED AND SPLIT AS RN TRIED TO PUSH IV DIRECT MEDICATION. 20% OF MEDICATION SPRAYED/LEAKED OUT OF SYRINGE. VERBATIM: PROBLEM INFORMATION: PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: (B)(6) 2024 SYRINGE BARREL CRACKED AND SPLIT AS RN TRIED TO PUSH IV DIRECT MEDICATION. 20% OF MEDICATION SPRAYED/LEAKED OUT OF SYRINGE. OCCURRENCES: 1 EA.

    Description of Event or Problem · 0

    MATERIAL# 302995 , BATCH# 4061797. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 BARREL WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: 19-APR-2024 SYRINGE BARREL CRACKED AND SPLIT AS RN TRIED TO PUSH IV DIRECT MEDICATION. 20% OF MEDICATION SPRAYED/LEAKED OUT OF SYRINGE. OCCURRENCES: 1 EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157677 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4061797 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown