BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP DISPOSABLE SYRINGE

    MDR report key: 12339972 · Received August 18, 2021

    Report

    Report Number
    9614033-2021-00095
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 20, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    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

    H.6. INVESTIGATION: PHOTOS RECEIVED FOR INVESTIGATION, THIS CATALOG NUMBER 309657 IS MANUFACTURED AT TWO DIFFERENT BD PLANTS, DEPENDING ON WHAT REGIONS HAVE BEEN REGISTERED FOR PRODUCTS MADE IN BOTH LOCATIONS THE LABEL MAY BE DIFFERENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE WAS INCORRECTLY LABELED AND MIXED IN WITH THE PLASTIPAK SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS PRODUCT IS BEING RETURNED DUE TO AN IDENTIFIED DEFECT ON PRODUCT MARKED MADE IN MEXICO." "THE CUSTOMER PROVIDED.. PICTURE AND LOT NUMBERS 1088375 (PLASTIPAK) AND 1043505 FOR THE OTHER PRODUCT NOT LABELED AS PLASTIPAK. BOTH ARE BEING REPORTED AS NON-USABLE PER THE CUSTOMER."

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK" TIP DISPOSABLE SYRINGE WAS INCORRECTLY LABELED AND MIXED IN WITH THE PLASTIPAK SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS PRODUCT IS BEING RETURNED DUE TO AN IDENTIFIED DEFECT ON PRODUCT MARKED MADE IN (B)(4)." "THE CUSTOMER PROVIDED.. PICTURE AND LOT NUMBERS 1088375 (PLASTIPAK) AND 1043505 FOR THE OTHER PRODUCT NOT LABELED AS PLASTIPAK. BOTH ARE BEING REPORTED AS NON-USABLE PER THE CUSTOMER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234087 BD LUER-LOK¿ TIP DISPOSABLE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 1043505 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown