BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 16019550 · Received December 20, 2022

    Report

    Report Number
    1213809-2022-01285
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 28, 2022
    Report Date
    February 8, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED BY THE CUSTOMER THAT A 5ML SYRINGE WAS FOUND WITH NO GRADUATION MARKS OR NUMBERS. TO AID IN THE INVESTIGATION, ONE SAMPLE OF A 5ML LUER LOK SYRINGE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PLUNGER ROD WAS SEPARATED FROM THE BARREL AND THE BARREL HAD NO MARKINGS. IT WAS ALSO OBSERVED THAT THE BARREL HAD A SMALL DENT ON THE OUTSIDE SURFACE, THERE WAS SOME FLASH AROUND THE BARREL FLANGE AND AT THE BARREL TIP AND A STICKY GLUE WAS PRESENT ON THE OUTSIDE OF THE BARREL. THE OBSERVED CONDITIONS ARE NON-CONFORMING PER PRODUCT SPECIFICATION AND ARE ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309703, LOT 2153044. THE REVIEW REVEALED THERE WERE NO INTERNAL REJECTS RELATED TO THE REPORTED ISSUE BY THE CUSTOMER. ACCORDING TO THE QUALITY RECORDS, ALL THE INSPECTIONS OF THE SAMPLING PLAN MET THE ACCEPTANCE CRITERIA. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF SYRINGES USED IN THE MANUFACTURING OF THIS BATCH WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE SCALE MARKING WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN YOU PLEASE HELP US TO INITIATE A COMPLAINT FOR 5ML SYRINGE FOUND WITH NO GRADUATION MARKS NOR NUMBERS? THIS IS FROM BD MATERIAL 309703, LOT 2153044.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE SCALE MARKING WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN YOU PLEASE HELP US TO INITIATE A COMPLAINT FOR 5ML SYRINGE FOUND WITH NO GRADUATION MARKS NOR NUMBERS? THIS IS FROM BD MATERIAL 309703, LOT 2153044.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051848 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309703 2153044 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown