BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BNS

    MDR report key: 19078134 · Received April 10, 2024

    Report

    Report Number
    1911916-2024-00252
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 8, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010351
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR WITH DEVICE EVALUATION. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. IT WAS REPORTED THERE WERE SLIP TIP SYRINGES MIXED IN WITH LUER LOCK SYRINGES. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS SYRINGES COVERED BY PLASTIC; ONE SYRINGE HAS A LUER SLIP AND THE REST OF THE SYRINGES HAVE A LUER LOCK. THE SECOND PHOTO SHOWS A SYRINGE WITH A LUER SLIP. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. THIS DEFECT COULD OCCUR IF LINE CLEARANCE WAS NOT PROPERLY PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT 3249315. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE PACKAGING PROCESS WAS PERFORMED, AND NO MIXED PRODUCT WAS OBSERVED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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

    ACCORDING TO THE SPECIFICATION OF MATERIAL K-01000-028B REV. 01 THE SYRINGE SHOULD BE LUER-LOCK 50 CC, IN A BAG OF MATERIAL K-01000-028B BATCH 33P23L0311 THERE WERE FOUND 22 SYRINGE LUER-SLIP 50 CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429177 SYRINGE 50ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 3249315 50382903010351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown