BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 14459132 · Received May 20, 2022

    Report

    Report Number
    9610847-2022-00189
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 13, 2022
    Report Date
    June 23, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903097029
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2021835. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026. H.4. DEVICE MANUFACTURE DATE: 16-FEB-2022. D.4. MEDICAL DEVICE LOT #: 2021832. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026. H.4. DEVICE MANUFACTURE DATE: 03-FEB-2022. D.4. MEDICAL DEVICE LOT #: 2028783. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026. H.4. DEVICE MANUFACTURE DATE: 22-FEB-2022.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 3 PHOTOS AND 24 LOOSE SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUES OF FOREIGN MATTER, WERE CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. SEVEN SAMPLES DISPLAYED EXCESSIVE SILICONE INSIDE THE SYRINGE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INTERNAL PARTICULATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INTERNAL PARTICULATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INTERNAL PARTICULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200054 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10. 00382903097029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown