BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE ORAL 1ML AMBER

    MDR report key: 20081095 · Received August 27, 2024

    Report

    Report Number
    1213809-2024-00586
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 13, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    UDI-DI
    50382903052078
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THAT: ¿GTIN / UDI PACKAGING INFORMATION INCORRECT IN GUDID FOR (B)(4) (BD 305207)¿. MATERIAL 305207 CONSISTS OF 500 NON-STERILE SYRINGES PACKAGED IN 5 POLYBAGS CONTAINING (B)(4) EACH. MATERIAL 305207 GUDID RECORD REFLECTS THE CURRENT LABEL ATTRIBUTES FOR THE SHELFPACK AND CASE. THE SHELFPACK REVISION 6 LABEL DID NOT CONTAIN AUTOMATIC IDENTIFICATION AND DATA CAPTURE (AIDC) FOR THE UNIQUE DEVICE IDENTIFIER (UDI) PRODUCTION IDENTIFIERS. THE PRIMARY DEVICE IDENTIFIER (DI) NUMBER USUALLY INDICATES THE LOWEST LEVEL OF PACKAGING THAT IS MARKED WITH A COMPLETE UNIQUE DEVICE IDENTIFIER (UDI) COMPLIANT LABEL. UNIQUE DEVICE IDENTIFIER (UDI) COMPLIANT LABEL INCLUDES BOTH THE DEVICE IDENTIFIER AND PRODUCTION IDENTIFIER. MATERIAL 305207 SHELFPACK LABEL HAS BEEN UPDATED TO REVISION 7 FOR EUMDR TO INCLUDE THE UNIQUE DEVICE IDENTIFIER AND PRODUCTION IDENTIFIER (UDI-PI) BARCODE. GUDID RECORD UPDATE WILL BE SUBMITTED TO UPDATE THE PRIMARY DEVICE IDENTIFIER (DI) NUMBER TO THE SHELFPACK (GTIN: (B)(4); DEVICE COUNT: (B)(4). BASED ON THE INVESTIGATION REPORTED ISSUE IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL #:305207 BATCH#:UNKNOWN IT WAS REPORTED THAT THE BD SYRINGE ORAL 1ML AMBER LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. GTIN / UDI PACKAGING INFORMATION INCORRECT IN GUDID FOR (B)(4) (BD 305207).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158336 BD SYRINGE ORAL 1ML AMBER CONTAINER, LIQUID MEDICATION, GRADUATED KYW BECTON DICKINSON MEDICAL SYSTEMS 50382903052078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown