BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP

    MDR report key: 14162568 · Received April 20, 2022

    Report

    Report Number
    3003152976-2022-00160
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 29, 2022
    Report Date
    January 11, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP THE TIP IS BROKEN THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...THERE ARE NO HOLES IN THE SYRINGE ITSELF TO DRAW UP THE MEDICINE...." PER CUSTOMER RESPONSE: YES THE TIP IS BROKEN AND IT IS MELTED SO U CANT PUT FLUID IN IT D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 17-DEC-2022. H6: INVESTIGATION SUMMARY ONE SAMPLE AND MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE TIP IS OBSERVED TO BE TWISTED AND DETACHED AND THE THUMB PRESS OF THE PLUNGER WAS BROKEN. THERE WAS NO EVIDENCE THE TIP WAS MELTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201099, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MACHINE MOLDING PARAMETERS WERE REVIEWED AND VERIFIED TO BE WITHIN REQUIRED LIMITS. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON THE SYRINGE TIPS OR PLUNGERS, THE TIP WERE PROPERLY MOLDED, AND FLUID COULD FLOW THROUGH THE TIP OF THE SYRINGE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE FOUND. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS POSSIBLE THE THUMBPRESS BROKE DURING MOVEMENT WITHIN THE MANUFACTURING EQUIPMENT. GIVEN THE DEVICE RECORDS DO NOT INDICATE AN ISSUE AND NO DEFECTS WERE OBSERVED IN THE RETAINED SAMPLES, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME IN RELATION TO THE ISSUE OBSERVED WITH THE TIP.

    Description of Event or Problem · 0

    IT WAS REPORTED BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP HAD A BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...THERE ARE NO HOLES IN THE SYRINGE ITSELF TO DRAW UP THE MEDICINE....".

    Description of Event or Problem · 0

    IT WAS REPORTED BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP THE TIP IS BROKEN THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...THERE ARE NO HOLES IN THE SYRINGE ITSELF TO DRAW UP THE MEDICINE...." PER CUSTOMER RESPONSE: YES THE TIP IS BROKEN AND IT IS MELTED SO U CANT PUT FLUID IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410756 BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2201099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown