BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19899775 · Received August 2, 2024

    Report

    Report Number
    1213809-2024-00517
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 19, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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

    IT WAS REPORTED THAT THE BD LUER-LOK BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: KESAVA RAJ M: 18-JUL-2024 FOLLOW-UP 1ST ATTEMPT COMMENTS (REC): " FIELD BELOW 1. PLEASE CONFIRM THE NUMBER OF PRODUCTS AFFECTED. ="FOR THE MOMENT, 1 SYRINGE." 2. HAS THERE BEEN ANY PATIENT IMPACT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? ="TREATMENT HAD TO BE RE-PREPARED. NO CLINICAL IMPACT ON THE PATIENT." 3. HAS THERE BEEN ANY HEALTHCARE WORKER¿S EXPOSURE TO BLOOD OR BODILY FLUIDS? ="NO". 4. HAVE ANY OTHER ACTIONS BEEN TAKEN? ="NO". 5. WERE THERE ANY NEGATIVE CONSEQUENCES FOR THE OPERATOR DUE TO THE LEAK OR FOR PATIENTS DUE TO THE MISSED ADMINISTRATION? ="LOSS OF TIME FOR NURSING STAFF, PREPARATION STAFF. WAITING TIME FOR INPATIENTS IN HDJ (DAY HOSPITAL)." 6. COULD YOU PROVIDE A NAME OF CHEMOTHERAPY MEDICATION THAT HAS BEEN USED WITH THE PRODUCT? ="THE INN OF THE PRODUCT IS AZACITIDINE". AN INCIDENT THAT OCCURRED ON (B)(6) 2024, DURING THE USE OF THE PRODUCT: "3-PIECE LUER SYRINGE 3 ML " -REF: (B)(4). -LOT NUMBER: 0245450. -EXP: 31/08/2025. DURING THE ADMINISTRATION OF CHEMOTHERAPY, THE IDE (USER) NOTICED A LEAKAGE IN THE BARREL OF THE SYRINGE. THE SYRINGE WAS CRACKED. THE SYRINGE WAS DISCARDED AND IS THEREFORE NOT AVAILABLE FOR RETURN OR APPRAISAL. VISUALLY, AT THE TIME OF PREPARATION, THERE WERE NO VISIBLE CRACKS ON THE SYRINGE. THE SYRINGE CONTAINING AN ANTI-CANCER TREATMENT HAD TO BE REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037711 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0245450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown