BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK SYRINGE

    MDR report key: 9819036 · Received March 11, 2020

    Report

    Report Number
    9614033-2020-00028
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 20, 2020
    Report Date
    May 8, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    K151766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-05-07. H.6. INVESTIGATION SUMMARY: SAMPLE RECEIVED FOR INVESTIGATION AND EVALUATED FOR LOOSE FOREIGN MATTER IN THE FLUID PATH, AND ANY PRESENCE OF LUBRICANT. THE INITIAL VISUAL INSPECTION OF THE ANALYZED SAMPLE IS CARRIED OUT AND THE DROPS REPORTED BY THE CLIENT, OR ANY TYPE OF PARTICLE IN THE FLUID PATH ARE NOT OBSERVED, FOR WHICH THE SAMPLE IS COMPLIANT. SUBSEQUENTLY, THE LUBRICANT PRESENCE TEST IS PERFORMED, RESULTING IN IT BEING ABOVE THE MAXIMUM SPECIFICATION, RULING AS NON-COMPLIANT. THE FACT THAT THE RESULT OF THE AMOUNT OF LUBRICANT IS ABOVE THE MAXIMUM ALLOWED COULD EXPLAIN THE DROPS OBSERVED BY THE CLIENT IN THE BARREL OF THE SYRINGE, HOWEVER, BEING A MEDICAL GRADE LUBRICANT DOES NOT JEOPARDIZE THE SAFETY OF THE USER, NOR DOES IT AFFECT THE FUNCTIONALITY OF THE SYRINGE. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE SILICONE DISPENSER FAILURE. SILICONE CONTENT TEST IS PERFORMED 2 TIMES PER SHIFT AS A PREVENTIVE MEASURE AND TO AVOID OUT OF SPECIFICATION RESULTS. NO CORRECTIVE ACTION ARE NECESSARY AT THE MOMENT. 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN DROPLETS WERE IN THE BD LUER LOK¿ SYRINGE BARREL BEFORE USE. LOT#'S 9072962 AND 9072978 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS SEEING CONDENSATION OR DROPLETS IN THE BARREL OF THE SYRINGE. AS THE PLUNGER IS PULLED BACK, IT COLLECTS THE DROPLETS AND THEY¿RE NO LONGER VISIBLE IN THE BARREL. PER THE CLINICIAN IT FEELS LIKE A LUBRICANT FOR THE PLUNGER."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9072962. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-04-12. MEDICAL DEVICE LOT #: 9072978. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-04-30. 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 DROPLETS WERE IN THE BD LUER LOK¿ SYRINGE BARREL BEFORE USE. LOT#'S 9072962 AND 9072978 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS SEEING CONDENSATION OR DROPLETS IN THE BARREL OF THE SYRINGE. AS THE PLUNGER IS PULLED BACK, IT COLLECTS THE DROPLETS AND THEY¿RE NO LONGER VISIBLE IN THE BARREL. PER THE CLINICIAN IT FEELS LIKE A LUBRICANT FOR THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285238 BD LUER LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other