BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 10072297 · Received May 19, 2020

    Report

    Report Number
    1213809-2020-00319
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    August 27, 2019
    Report Date
    May 28, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096480
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : ONE PHOTO OF A MAGNIFIED PARTICLE WAS RECEIVED. THE PARTICLE APPEARED TAN IN COLOR AND COULD NOT BE VISUALLY IDENTIFIED. THE PARTICLE WAS REPORTED IN THE FLUID PATH OF THE SYRINGE AND APPROXIMATELY 650 MICROMETERS IN LENGTH, WHICH WOULD BE LARGER THAN LEVEL 2 IN SIZE AND REJECTABLE PER PRODUCT SPECIFICATION. THE COMPOSITION WAS REPORTED WITH THE BEST MATCH TO BE PARTICLE BOARD THROUGH FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) . THIS INDICATES THE PARTICLE WAS LIKELY A SMALL CARDBOARD FRAGMENT AS THE PRODUCT IS PACKAGED IN A LARGE PLASTIC BAG INSIDE A CARDBOARD BOX AND SOLD AS NON-STERILE. 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. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. IT IS POSSIBLE A CARDBOARD FRAGMENT WAS INADVERTENTLY INTRODUCED INTO THE BAG DURING THE LOADING OF PRODUCT OR MANUALLY TYING THE BAG. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 8271675 AND 8190590 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FOUND SMALL FIBRE IN SYRINGE BEFORE SURGERY."

    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 FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FOUND SMALL FIBRE IN SYRINGE BEFORE SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536993 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8271675 00382903096480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other