BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19667762 · Received July 3, 2024

    Report

    Report Number
    1213809-2024-00425
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, 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. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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#: 309628, BATCH NUMBER#: 3011963. IT WAS REPORTED BY CUSTOMER THAT CRACKED SYRINGE. THE LOCATION OF THE CRACK IS UNKNOWN AT THIS TIME. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CRACKED SYRINGE. THE LOCATION OF THE CRACK IS UNKNOWN AT THIS TIME. FOLLOW UP ATTEMPTS ARE ONGOING WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION. ITEM -309628. LOT - 3011963.

    Description of Event or Problem · 0

    MATERIAL#: 309628; BATCH NUMBER#: 3011963. IT WAS REPORTED THAT THE SYRINGE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CRACKED SYRINGE. THE LOCATION OF THE CRACK IS UNKNOWN AT THIS TIME. FOLLOW UP ATTEMPTS ARE ONGOING WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION. ITEM -309628, LOT - 3011963. ADDITIONAL INFORMATION PROVIDED: PLEASE PROVIDE THE LOCATION OF THE CRACK IF RECEIVED? UNKNOWN. DID THE DEFECT FIND BEFORE THE USE? THE AFFECTED SYRINGE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977530 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3011963 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown