BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL S/C 200

    MDR report key: 10743609 · Received October 27, 2020

    Report

    Report Number
    1213809-2020-00750
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    October 2, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION? YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6) 2020. H.6. INVESTIGATION: 1 SYRINGE WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. IT WAS REPORTED THAT THE USER HAD TROUBLE FLUSHING THROUGH THE EXTENSION SET. THE SYRINGE WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SYRINGE WAS FILLED WITH 10 ML OF BLUE DYE/WATER MIXTURE, CONNECTED TO EACH EXTENSION SET AND ATTEMPTED TO BE INFUSED. ALL SETS WERE ABLE TO BE INFUSED. THE FAILURE WAS UNABLE TO BE REPLICATED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 302995 LOT NUMBER 0070362 WAS PERFORMED, HOWEVER, THE LOT SHOWED NO DATA. A ROOT CAUSE COULD NOT BE DETERMINED. A TREND FOR THIS OCCLUSION ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE. CAPA#1998036 HAS BEEN INITIATED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 20039E BATCH NO: 20075476. IT WAS REPORTED THAT THE USER HAD TROUBLE FLUSHING THROUGH THE EXTENSION SET.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 20039E ; BATCH NO: 20075476 IT WAS REPORTED THAT THE USER HAD TROUBLE FLUSHING THROUGH THE EXTENSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209227 SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 0070362 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1