BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 15546622 · Received October 5, 2022

    Report

    Report Number
    9610847-2022-00385
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 26, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903096800
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2123419, MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027, DEVICE MANUFACTURE DATE: 31-MAY-2022; MEDICAL DEVICE LOT #: 2123419, MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027, DEVICE MANUFACTURE DATE: 20-JUN-2022.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 2 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED DURING THE MICROSCOPIC INSPECTION OF THE SAMPLES. BD CANNOT DETERMINE THE CAUSE OF THE FAILURE SINCE THE DEFECT WAS NOT CONFIRMED. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH WAS IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGE HAS FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE SYRINGES WITH COSMETIC AND PARTICULATE DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGE HAS FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE SYRINGES WITH COSMETIC AND PARTICULATE DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859357 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H10 00382903096800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown