BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 12962396 · Received December 8, 2021

    Report

    Report Number
    1213809-2021-00804
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 9, 2021
    Report Date
    December 21, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. 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

    H.6. INVESTIGATION: SEVEN PHOTOS WERE RECEIVED AND EVALUATED. TWO PHOTOS SHOWED A SYRINGE WITH AN UNKNOWN MEDICATION DRAWN INTO THE BARREL, IN BOTH PHOTOS A LARGE SMEARING OF WHITE FOREIGN MATTER WAS PRESENT IN THE FLUID PATH. ONE PHOTO SHOWED A MAGNIFIED VIEW OF A PLUNGER-STOPPER ASSEMBLY REMOVED FROM ITS BARREL WITH NO VISIBLE DEFECTS PRESENT. ONE PHOTO SHOWED A MAGNIFIED VIEW OF A PLUNGER-STOPPER ASSEMBLY WITH VISIBLE SILICONE LUBRICANT PRESENT ON THE STOPPER, THE SILICONE SHOWN WAS THE EXPECTED AMOUNT. ONE PHOTO SHOWED A MAGNIFIED VIEW OF A PLUNGER-STOPPER THAT HAD SEVERAL DRIED FLAKES OF LOOSE WHITE FOREIGN MATTER PRESENT ON THE SURFACE OF THE STOPPER. TWO PHOTOS SHOWED A REMOVED PLUNGER-STOPPER ASSEMBLY WITH WHAT APPEARED TO BE WHITE FOREIGN MATTER PRESENT. THE FOREIGN MATTER OBSERVED APPEARS TO POSSIBLY BE BOTH LIQUID AND DRIED SILICONE LUBRICANT. UNUSED PHYSICAL SAMPLES WITH THE PLUNGER RODS NOT REMOVED FROM THE BARREL ARE NEEDED TO PERFORM A MORE IN-DEPTH EVALUATION AND TO HAVE FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING CONDUCTED TO DEFINITIVELY DETERMINE THE FOREIGN MATTER COMPOSITION. 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.STOPPERS ARE WASHED AND LUBRICATED WITH SILICONE PRIOR TO THE ASSEMBLY PROCESS. ADDITIONALLY, SILICONE IS APPLIED AS A SPRAY OF PARTICLES TO THE INSIDE OF THE BARREL DURING ASSEMBLY. IT IS UNCLEAR WHAT TYPE OF STORAGE AND HANDLING CONDITIONS THE PRODUCT WAS SUBJECTED TO AFTER LEAVING THE MANUFACTURING PLANT. IT IS POSSIBLE CERTAIN CONDITIONS OUTSIDE THE MANUFACTURING ENVIRONMENT CONTRIBUTED TO THE DRYING OF SILICONE TO THE STOPPER. SINCE ROOT CAUSE FOR THE FOREIGN MATTER COULD NOT BE DETERMINED AND A PHYSICAL SAMPLE WAS NOT RECEIVED TO PERFORM FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS TO DEFINITIVELY IDENTIFY THE DEFECT, CORRECTIVE ACTIONS ARE NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT: PLUNGER DEFECTS WERE DETECTED (FM ON PLUNGER)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT : PLUNGER DEFECTS WERE DETECTED(FM ON PLUNGER). "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859209 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309605 1041907 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown