BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9475108 · Received December 16, 2019

    Report

    Report Number
    3002682307-2019-00668
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    September 2, 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

    BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301942 LOT 1811184 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 HAS BEEN REPORTED THAT ONE BD¿ SYRINGE S2 5ML 22GA 1-1/4IN HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, WHEN THE NURSE WAS DISPENSING ASTHMA DRUGS TO THE PATIENT, SHE FOUND FOREIGN MATTER IN THE 5ML SYRINGE, AND SHE REPLACED THE NEW SYRINGE WITHOUT CAUSING ANY HARM TO THE PATIENT IN TIME.

    Additional Manufacturer Narrative · 1

    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 HAS BEEN REPORTED THAT ONE BD¿ SYRINGE S2 5ML 22GA 1-1/4IN HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, WHEN THE NURSE WAS DISPENSING ASTHMA DRUGS TO THE PATIENT, SHE FOUND FOREIGN MATTER IN THE 5ML SYRINGE, AND SHE REPLACED THE NEW SYRINGE WITHOUT CAUSING ANY HARM TO THE PATIENT IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272011 BD SYRINGE S2 5ML 22GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1811184

    Patients

    Seq Age Sex Outcome Treatment
    1 Other