BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ 1-ML SYRINGE

    MDR report key: 16261154 · Received January 28, 2023

    Report

    Report Number
    1213809-2023-00043
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    January 9, 2023
    Report Date
    February 9, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT SEVERAL DUST-LIKE FIBERS PRESENT ON AND IN THE TIP OF THE SYRINGE. POTENTIAL ROOT CAUSE FOR THE LOOSE FOREIGN MATTER IN THE UNIT PACKAGE DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. IT IS POSSIBLE THAT PARTICULATE/FIBER ACCUMULATION DUE TO EXCESS STATIC ELECTRICITY WAS PRESENT ON THE TOP WEB PACKAGING WHICH RESULTED IN THE FOREIGN MATTER BEING SEALED IN THE UNIT PACKAGE. SINCE MANUFACTURE OF THIS BATCH A TOP WEB DEIONIZER HAS BEEN INSTALLED ON THIS LINE TO AID IN REDUCTION OF STATIC BUILDUP ON PACKAGING MATERIAL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0043411. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ 1-ML SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LUER-LOK 1ML SYRINGE HAD UNKNOWN SUBSTANCE, POSSIBLY CARDBOARD ATTACHED TO THE SYRINGE TIP. 10-JAN-2023 - PICTURE REVIEW BY RCC, BROWNISH FOREIGN MATTER OBSERVED INSIDE THE SEALED PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ 1-ML SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LUER-LOK 1ML SYRINGE HAD UNKNOWN SUBSTANCE, POSSIBLY CARDBOARD ATTACHED TO THE SYRINGE TIP. (B)(6) 2023 - PICTURE REVIEW BY RCC, BROWNISH FOREIGN MATTER OBSERVED INSIDE THE SEALED PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846282 BD LUER-LOK¿ 1-ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0043411 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown