BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    MDR report key: 9520695 · Received December 26, 2019

    Report

    Report Number
    3002682307-2019-00686
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 4, 2019
    Report Date
    December 31, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301942 LOT 1811192 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA THERE WAS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE TAKING THE MEDICINE, THE SYRINGE'S PACKAGE WAS OPENED. WHEN THE NURSE CHECKED THE SYRINGE, A BLACK FOREIGN MATTER WAS FOUND IN THE SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA THERE WAS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: BEFORE TAKING THE MEDICINE, THE SYRINGE'S PACKAGE WAS OPENED. WHEN THE NURSE CHECKED THE SYRINGE, A BLACK FOREIGN MATTER WAS FOUND IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317034 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other