BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8509479 · Received April 12, 2019

    Report

    Report Number
    1213809-2019-00435
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 25, 2019
    Report Date
    June 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010738
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD LUER-LOK¿ SYRINGE THE STOPPER WAS CLAMPED/GLUED THE CYLINDER OF THE SYRINGE AGAINST THE CONE. THE LIQUID CANNOT BE SUCKED INTO SYRINGE OR PUMPED SMOOTHLY INTO THE SYRINGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: CUSTOMER REPORTED THAT DURING USE OF THE SYRINGE IT WAS FOUND THAT STOPPERS ARE 'CLAMPED/GLUED' IN THE CYLINDER OF THE SYRINGE, AGAINST THE CONE. THE SILICONIZED CAP SHOULD ALLOW A SMOOTH MOVEMENT OF THE PLUNGER. HOWEVER, THE LIQUID CANNOT BE SUCKED INTO A FLUID OR PUMPED SMOOTHLY INTO THE SYRINGE; THE PLUNGER STICKS IN THE CYLINDER AND / OR MOVES VERY ROUGHLY, THERE IS NO QUESTION OF A SMOOTH FLOW OF LIQUID IN THE SYRINGE. DURING THE PRODUCTION PROCESS, THIS DEFECT DOES NOT BRING THE CORRECT VOLUME OF MEDICINE INTO THE SYRINGE, I.E. PREPARATION BATCHES MUST BE REJECTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6206718, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2016-07-24. MEDICAL DEVICE LOT #: 8090720, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2018-03-31. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD LUER-LOK¿ SYRINGE THE STOPPER WAS CLAMPED/GLUED THE CYLINDER OF THE SYRINGE AGAINST THE CONE. THE LIQUID CANNOT BE SUCKED INTO SYRINGE OR PUMPED SMOOTHLY INTO THE SYRINGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT DURING USE OF THE SYRINGE IT WAS FOUND THAT STOPPERS ARE 'CLAMPED/GLUED' IN THE CYLINDER OF THE SYRINGE, AGAINST THE CONE. THE SILICONIZED CAP SHOULD ALLOW A SMOOTH MOVEMENT OF THE PLUNGER. HOWEVER, THE LIQUID CANNOT BE SUCKED INTO A FLUID OR PUMPED SMOOTHLY INTO THE SYRINGE; THE PLUNGER STICKS IN THE CYLINDER AND / OR MOVES VERY ROUGHLY, THERE IS NO QUESTION OF A SMOOTH FLOW OF LIQUID IN THE SYRINGE. DURING THE PRODUCTION PROCESS, THIS DEFECT DOES NOT BRING THE CORRECT VOLUME OF MEDICINE INTO THE SYRINGE, I.E. PREPARATION BATCHES MUST BE REJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304959 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903010738

    Patients

    Seq Age Sex Outcome Treatment
    1 Other