BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE NRFIT¿ LOK

    MDR report key: 20510019 · Received October 22, 2024

    Report

    Report Number
    1213809-2024-00748
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    October 1, 2024
    Report Date
    November 14, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - MIXED PRODUCT / LOTS. ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO SHOWS A STRIP OF FIVE SYRINGE PACKAGES WITH THE TOP WEB VISIBLE INCLUDING ALL APPLICABLE PRODUCT INFORMATION, AND ONE LOOSE SYRINGE WITH NRFIT SCALE MARKINGS ON A LUER-LOK BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MIXED PRODUCT DEFECT IS ASSOCIATED WITH INADEQUATE LINE CLEARANCE ON THE MARKING MACHINERY AND FAILURE TO FOLLOW PROPER PROCEDURES FOR GOODS ISSUING. A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE THIS DEFECT. A QUALITY ALERT WAS ISSUED TO THE SITE AND ASSOCIATES INVOLVED IN BATCH MANUFACTURING WERE RE-TRAINED TO PROPER MANUFACTURING PRACTICES AROUND LINE CLEARANCES, GOODS ISSUES, AND MATERIAL HANDLING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE NRFIT¿ LOK HAD MIXED PRODUCT / LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES MARKED AND PACKAGED AS BEING NRFIT¿ BUT WITH THE LUER CONNECTOR!!! BEFORE USE SYRINGES MARKED AND PACKAGED AS BEING NRFIT¿ BUT WITH THE LUER CONNECTOR, PLEASE SEE ATTACHED PICTURE. THEY HAVE ASKED THEIR 3PL DISTRIBUTOR (ONEMED) TO STOP ALL OUTGOING DELIVERIES TO THE HOSPITALS. THE COMPLAINANT HAS ASKED FOR AN URGENT MEETING WITH ME TODAY TO DISCUSS THE COMPLAINT AND I WILL TRY TO GET AS MUCH INFORMATION AS POSSIBLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565876 BD SYRINGE NRFIT¿ LOK PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT QEH BECTON DICKINSON MEDICAL SYSTEMS 1041220 00382904001742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown