BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE CONTROL 10ML LL BNS

    MDR report key: 19600836 · Received June 24, 2024

    Report

    Report Number
    1213809-2024-00410
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 27, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    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

    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.

    Description of Event or Problem · 0

    MATERIAL: 304134 BATCH#: (B)(4). IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL BNS WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT CONTROL SYRINGE WAS DEFECTIVE. ADDITIONAL INFORMATION PROVIDED: 1. COULD YOU PLEASE ELABORATE THE ISSUE WHAT ACTUALLY THE DAMAGED WAS. THE CONTROL SYRINGE WAS ALLOWING AIR TO BE INTRODUCED INCREASING RISK OF AIR EMBOLUS TO PATIENT. 2. CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? TWO CONTROL SYRINGES WERE SAVED AND RETURNED TO GEOFFREY STINEBAUGH THE MERIT MEDICAL CLINICAL REPRESENTATIVE. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO THERE WAS NO ADVERSE OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL

    Description of Event or Problem · 0

    MATERIAL: 304134. BATCH#: 4052885 . IT WAS REPORTED BY THE CUSTOMER THAT CONTROL SYRINGE WAS DEFECTIVE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER REPORTED THAT CONTROL SYRINGE WAS DEFECTIVE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101976 BD SYRINGE CONTROL 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4052885

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown