BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/BLUNT PLASTIC CANN

    MDR report key: 11667827 · Received April 14, 2021

    Report

    Report Number
    1213809-2021-00224
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903033461
    PMA / PMN Number
    K974363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED THE TOP VIEW OF A PACKAGE FROM BATCH 1043495 (P/N 303346). ONE PHOTO DISPLAYED A MEDICATION VIAL WITH A SMALL CYLINDRICAL FOREIGN MATTER PARTICLE. THE PARTICLE APPEARED TO BE A PIECE OF THE SEPTUM. IT IS POSSIBLE THE PRODUCT WAS NOT USED WITH THE APPROPRIATE SEPTUM. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS LIKELY ASSOCIATED WITH THE CUSTOMER MISUSE. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL W/BLUNT PLASTIC CANN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303346, BATCH NO: 1043495. IT WAS REPORTED THAT PLASTIC RUBBER PIECES ARE BREAKING OFF INTO THE VIAL WHEN SYRINGES ARE BEING USED. VERBATIM: CATH LAB MANAGER CAME TO PATIENT SAFETY TO NOTIFY OF THE ABOVE CONCERN: A NURSE IN THE CATH LAB STATED SHE HAS NOTICED ON ALMOST EVERY SINGLE FENTANYL THAT PLASTIC RUBBER PIECES ARE BREAKING OFF INTO THE VIAL WHEN SHE USES THE ABOVE SYRINGES. CONCERNS VOICED AS THESE MEDS ARE SOMETIMES GIVEN INTRA ARTERIAL AND CONCERNS OF DRAWING UP SMALL PLASTIC PIECES. WHEN THIS WAS VOICED WE PULLED ALL BD SYRINGES AT WASHINGTON HOSPITAL. SAFE BEING PLACED BY PATIENT SAFETY MANAGER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL W/BLUNT PLASTIC CANN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303346. BATCH NO: 1043495. IT WAS REPORTED THAT PLASTIC RUBBER PIECES ARE BREAKING OFF INTO THE VIAL WHEN SYRINGES ARE BEING USED. VERBATIM: CATH LAB MANAGER CAME TO PATIENT SAFETY TO NOTIFY OF THE ABOVE CONCERN: A NURSE IN THE CATH LAB STATED SHE HAS NOTICED ON ALMOST EVERY SINGLE FENTANYL THAT PLASTIC RUBBER PIECES ARE BREAKING OFF INTO THE VIAL WHEN SHE USES THE ABOVE SYRINGES. CONCERNS VOICED AS THESE MEDS ARE SOMETIMES GIVEN INTRA ARTERIAL AND CONCERNS OF DRAWING UP SMALL PLASTIC PIECES. WHEN THIS WAS VOICED WE PULLED ALL BD SYRINGES AT WASHINGTON HOSPITAL. SAFE BEING PLACED BY PATIENT SAFETY MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562570 SYRINGE 3ML LL W/BLUNT PLASTIC CANN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 1043495 00382903033461

    Patients

    Seq Age Sex Outcome Treatment
    1