BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE NRFIT¿ LOK

    MDR report key: 19346824 · Received May 17, 2024

    Report

    Report Number
    1213809-2024-00296
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 26, 2024
    Report Date
    November 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    QEH
    UDI-DI
    00382904001742
    PMA / PMN Number
    K192538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ONE HUNDRED AND NINETY-FIVE SAMPLES AND ONE PHOTO OF 10ML NRFIT SYRINGES WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE SAMPLES AND PHOTO FROM BATCH 1041220 REGARDING ITEM 400174. ALL SAMPLES WERE RECEIVED IN SEALED PACKAGES WITH ALL APPLICABLE PRODUCT INFORMATION ON THE PACKAGE, AND THE SAMPLES WERE ALL FOUND TO BE ACCEPTABLE WITH NO DEFECTS OBSERVED; HOWEVER, THE PHOTO SHOWED TWO SEALED SYRINGES NEXT TO EACH OTHER WITH ONE BEING A STANDARD LUER-LOK SYRINGE TIP AND THE OTHER BEING AN NRFIT BARREL TIP. THE OBSERVED MIXED PRODUCT CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION.POTENTIAL ROOT CAUSE FOR THE MIXED PRODUCT DEFECT IS ASSOCIATED WITH INADEQUATE LINE CLEARANCE ON THE MARKING MACHINERY. A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE THIS DEFECT. MANUFACTURING PERSONNEL WILL BE NOTIFIED OF THIS INCIDENT AND ADDITIONAL TRAINING WILL BE PROVIDED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1041220. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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 THE BD SYRINGE NRFIT¿ LOK WITH MIXED PRODUCT/LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS LOTS OF REFERENCE ARE MIXED SYRINGES NRFIT WITH SYRINGES LUERLOCK, . ALL WITHIN THE SAME BOX WITH THE SAME REFERENCE (NRFIT) AND THE SAME ASSEMBLY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381715 BD SYRINGE NRFIT¿ LOK NEURAXIAL SYRINGE QEH BECTON DICKINSON MEDICAL SYSTEMS 1041220 00382904001742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown