BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE

    MDR report key: 9412303 · Received December 4, 2019

    Report

    Report Number
    1213809-2019-01212
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 15, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095750
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE LOOSE 3ML SYRINGE WITH NEEDLE AND THE TOP WEB OF A BLISTER PACK FROM BATCH 8253881 (P/N 309575) WERE RECEIVED AND EVALUATED. AFTER REMOVING THE SHIELD, IT WAS OBSERVED THERE WERE A LARGE AMOUNT OF SMALL WHITE FOREIGN MATTER FIBERS PRESENT INSIDE OF THE SHIELD, ON THE CANNULA AND IN THE FLUID PATH. THE DEBRIS WAS THEN EXAMINED USING 40X MAGNIFICATION AND WAS VISUALLY IDENTIFIED AS PLASTIC. POSSIBLE ROOT CAUSE, PLASTIC DUST MAY BE CREATED THROUGHOUT THE MANUFACTURING PROCESS VIA CONVEYING AND VIBRATION OF PLASTIC COMPONENTS. IT APPEARS THAT SOME OF THIS DUST WAS IN THE NEEDLE SHIELD WHEN THE NEEDLE SHIELD WAS PRESSED ON THE NEEDLE HUB ASSEMBLY. THIS IS THE FIRST (1ST) COMPLAINT WITH ONE (1) REPORTED OCCURRENCE, THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ON NEEDLE WITH A BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS NOTED THAT THEY CANNOT DETERMINE WHAT THE FM IS ON THE NEEDLE (FUZZ, METAL, ETC.).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ON NEEDLE WITH A BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS NOTED THAT THEY CANNOT DETERMINE WHAT THE FM IS ON THE NEEDLE (FUZZ, METAL, ETC.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208866 BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309575 8253881 30382903095750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other