BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 15126878 · Received July 28, 2022

    Report

    Report Number
    1213809-2022-00426
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 28, 2022
    Report Date
    August 2, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SIX 10ML LUER-LOCK SYRINGES (P/N 302995) BATCH 2091690 WERE RECEIVED AND EVALUATED. ONE SYRINGE PACKAGE HAS NO DEFECT UPON IT. TWO PACKAGES ARE STUCK TOGETHER WITHOUT A GOOD PERFORATION. TWO PACKAGES HAVE BEEN TORN APART WITHOUT GOOD PERFORATION AND THE WEB IS TORN. ONE PACKAGE IS TORN INTO THE BOTTOM WEB WHICH AFFECTS THE STERILITY OF THE SYRINGE. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE POOR PACKAGE PERFORATION DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 2091690 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2091690. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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 IS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP PACKAGING HAD POOR PERFORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE ATTEMPTED TO TEAR 'SINGLE' SYRINGE OFF PACKAGING STRIP. THEY WERE UNABLE TO DO SO WITHOUT TEARING THE ENTIRE STRIP OPEN."

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP PACKAGING HAD POOR PERFORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE ATTEMPTED TO TEAR 'SINGLE' SYRINGE OFF PACKAGING STRIP. THEY WERE UNABLE TO DO SO WITHOUT TEARING THE ENTIRE STRIP OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426051 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 2091690 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown