BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE TIP CAP

    MDR report key: 8233225 · Received January 10, 2019

    Report

    Report Number
    1911916-2018-00834
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 21, 2018
    Report Date
    February 21, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TEN REPRESENTATIVE SAMPLES WERE RECEIVED. THEY WERE VISUALLY INSPECTED UNDER THE MICROSCOPE. A FUNCTIONAL TEST WAS PERFORMED BY CONNECTING THEM TO A SALINE SYRINGE, THE PLUNGER ROD OF THE SYRINGE WAS PUSHED DOWN TRYING TO EXPEL THE SALINE SOLUTION. NO LEAKAGE WAS OBSERVED, THEREFORE FAILURE MODE IS NOT VERIFIED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE TIP CAP THERE WERE 2 ISSUES WITH LEAKAGE FROM THE SEAL BETWEEN THE CAP AND THE SYRINGE, ONCE WITH LOT# 7200661 AND ONCE WITH 8207911.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7200661. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2017-07-19. MEDICAL DEVICE LOT #: 8207911. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-07-26. 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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE TIP CAP THERE WERE 2 ISSUES WITH LEAKAGE FROM THE SEAL BETWEEN THE CAP AND THE SYRINGE, ONCE WITH LOT# 7200661 AND ONCE WITH 8207911.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27813 BD¿ SYRINGE TIP CAP LIQUID MEDICATION DISPENSER KYW BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other