BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE

    MDR report key: 16287779 · Received February 2, 2023

    Report

    Report Number
    1213809-2023-00057
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 12, 2023
    Report Date
    February 17, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 07-FEB-2023. H6: INVESTIGATION SUMMARY: TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT A CLEAR GEL LIKE MATERIAL STRINGING FROM THE BARREL ROOF AGAINST THE STOPPER. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS RESULTS SHOWED THAT THE FOREIGN MATTER WAS SILICONE LUBRICANT USED IN THE MANUFACTURING PROCESS. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2042752. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ 3ML SYRINGE FOREIGN MATTER WAS FOUND. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR CLINICAL STAFF FOUND WITH A SMALL AMOUNT OF CLEAR, STICKY SUBSTANCE FOUND INSIDE THE SYRINGE. WE REVIEWED ADDITIONAL SYRINGES IN THAT LOT AND LOCATED SEVERAL MORE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ 3ML SYRINGE FOREIGN MATTER WAS FOUND. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR CLINICAL STAFF FOUND WITH A SMALL AMOUNT OF CLEAR, STICKY SUBSTANCE FOUND INSIDE THE SYRINGE. WE REVIEWED ADDITIONAL SYRINGES IN THAT LOT AND LOCATED SEVERAL MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347821 BD PLASTIPAK¿ 3ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2042752 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown