BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP DISPOSABLE SYRINGE

    MDR report key: 13006431 · Received December 14, 2021

    Report

    Report Number
    1213809-2021-00816
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 17, 2021
    Report Date
    January 13, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1210161; D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2026; H.4. DEVICE MANUFACTURE DATE: 7/29/2021. D.4. MEDICAL DEVICE LOT #: 9259196; D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2024; H.4. DEVICE MANUFACTURE DATE:9/16/2019. D.4. MEDICAL DEVICE LOT #: 0094153; D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2025; H.4. DEVICE MANUFACTURE DATE: 4/3/2020. D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/30/2021. H.6. INVESTIGATION: TWO HUNDRED AND EIGHTY-SIX 3ML SYRINGES (P/N 309657) SEALED IN THEIR BLISTER PACKS AND TWO LOOSE 3ML SYRINGES WITH ECLIPSE NEEDLES NOT PRODUCED AT BD CANAAN WERE RECEIVED. TWENTY-THREE WERE FROM BATCH #1210161, ONE HUNDRED AND NINETEEN WERE FROM BATCH #9259196, AND ONE HUNDRED AND FORTY-FOUR WERE FROM BATCH #0094153, WITH THE TWO LOOSE SAMPLES BEING FROM AN UNKNOWN LOT. THE SAMPLES WERE VISUALLY EVALUATED. NO VISUAL DEFECTS WERE OBSERVED ON ANY OF THE SAMPLES AND ALL PRODUCTS WERE ACCEPTABLE PER PRODUCT SPECIFICATION. THE "STICKY" SUBSTANCE NOTED IN THE VERBATIM IS MOST LIKELY SILICONE LUBRICANT USED IN THE ASSEMBLY PROCESS OF WHICH THE NORMAL EXPECTED AMOUNT WAS PRESENT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE SYRINGES HAVE A STICKY SUBSTANCE INSIDE OF THEM.   SYRINGES HAVE STICKY SUBSTANCE INSIDE THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE SYRINGES HAVE A STICKY SUBSTANCE INSIDE OF THEM.   SYRINGES HAVE STICKY SUBSTANCE INSIDE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895420 BD LUER-LOK¿ TIP DISPOSABLE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 SEE H.10 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown