BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7322722 · Received March 7, 2018

    Report

    Report Number
    1213809-2018-00159
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 15, 2018
    Report Date
    April 30, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SAMPLES FROM 15 LOTS WERE RECEIVED AND EVALUATED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR MAIN PRODUCT DEFECTS IDENTIFIED: PRINT DEFECTS; MISSING AND SMEAR PRINT. THE MOST LIKELY ROOT CAUSE IS RELATED TO MACHINE SET UP AT THE BEGINNING OF THE RUN. IT IS POSSIBLE THAT SEVERAL SYRINGES WERE IMPACTED EARLY IN THE PRODUCTION LOT AND NOT PROPERLY DETECTED AND DISCARDED BY PERSONNEL. CORRECTIVE ACTIONS FOR PRINTERS ASSOCIATED WITH HIGH DEFECTIVE RATES IDENTIFIED WILL BE REQUIRED. FOR EMBEDDED FOREIGN MATTER (EFM); BURNED RESIN. THE EMBEDDED PARTICLES OBSERVED ARE DEGRADED PLASTIC FROM THE COMPONENT MOLDING OPERATION. DEGRADED PLASTIC OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING PRESS. SMALL PARTICLES OF THE DEGRADED PLASTIC CAN BECOME LOOSE AND FLOW INTO THE INDIVIDUAL MOLD CAVITY. EMBEDDED FOREIGN MATTER CAN BE VISIBLE AS BROWN OR BLACK PARTICLES IN THE MOLDED COMPONENT. IT IS IMPORTANT TO CLARIFY THAT THIS CONDITION OCCURS AT VERY LOW FREQUENCY IN THE MOLDING PROCESS. CURRENT CONTROLS IN PLACE: PROPER CORRECTIVE ACTIONS ARE BEING IMPLEMENTED FOR THE MAIN ISSUES IDENTIFIED IN THE SAMPLES EVALUATED. OUR MANUFACTURING PROCESSES ARE VALIDATED TO MEET VARIOUS DIFFERENT GLOBAL REGULATORY REQUIREMENTS. WE DO CONDUCT IN-PROCESS INSPECTION AT DIFFERENT POINTS WITHIN OUR MANUFACTURING PROCESS TO ENSURE WE MEET PRODUCT SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7150679. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2017-05-30. MEDICAL DEVICE LOT #: 7237636 MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2017-08-25. MEDICAL DEVICE LOT #: 7001751. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2017-01-01.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD SYRINGE LUER-LOK¿ TIP WAS FOUND WITH MULTIPLE ISSUES AS THE SYRINGE WAS FOUND ¿CRACKED/DAMAGED, BLACK PRINT MARKS AND MISSING PRINT¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165657 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other