BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 9504581 · Received December 20, 2019

    Report

    Report Number
    3002682307-2019-00683
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    December 29, 2018
    Report Date
    January 24, 2020
    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 1801198 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPER IN THE BD¿ SYRINGE WAS DEFECTIVE AND DIDN'T "MATCH WITH THE BARREL", RESULTING IN DRUG LEAKAGE PAST IT DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE STOPPER OF THE 5ML SYRINGE DOES NOT MATCH WITH THE BARREL, RESULTING IN THE LEAKAGE OF DRUG FLUID AT THE STOPPER DURING INTRAVENOUS INJECTION OF THE DRUG, AND THE DRUG CANNOT FULLY PLAY ITS ROLE."

    Additional Manufacturer Narrative · 1

    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 THAT THE STOPPER IN THE BD¿ SYRINGE WAS DEFECTIVE AND DIDN'T "MATCH WITH THE BARREL", RESULTING IN DRUG LEAKAGE PAST IT DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE STOPPER OF THE 5ML SYRINGE DOES NOT MATCH WITH THE BARREL, RESULTING IN THE LEAKAGE OF DRUG FLUID AT THE STOPPER DURING INTRAVENOUS INJECTION OF THE DRUG, AND THE DRUG CANNOT FULLY PLAY ITS ROLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302437 BD SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1801198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other