BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 10 ML

    MDR report key: 14621318 · Received June 7, 2022

    Report

    Report Number
    1213809-2022-00319
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    April 30, 2022
    Report Date
    June 17, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 1-JUN-2022. H6: INVESTIGATION SUMMARY: THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION BARREL CRACK IS OBSERVED ON ALL THREE SAMPLES. THE AIR BUBBLES WERE NOT OBSERVED AS THE FLUID HAD BEEN REMOVED FROM THE SYRINGE. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 2034065 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2034065. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED TWO TIMES THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 10 ML, WERE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO EMPTY 10 CC SYRINGES WERE CRACKED TODAY. I DID NOT DROP THEM OR STEP ON THEM OR ANYTHING. THIS HAS NEVER HAPPENED TO ME BEFORE.

    Description of Event or Problem · 0

    IT WAS REPORTED TWO TIMES THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 10 ML, WERE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO EMPTY 10 CC SYRINGES WERE CRACKED TODAY. I DID NOT DROP THEM OR STEP ON THEM OR ANYTHING. THIS HAS NEVER HAPPENED TO ME BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602970 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 10 ML PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 2034065 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown