BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML PERFUSION

    MDR report key: 9112305 · Received September 24, 2019

    Report

    Report Number
    3003152976-2019-00662
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 8, 2019
    Report Date
    October 10, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1902205, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1902205 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN FILLING DIFFUSER PUMP WITH SYRINGE, MEDICATION LEAKED WITH A BD SYRINGE 50ML PERFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THIS SYRINGE WAS USED TO FILL A CHEMOTHERAPY DIFFUSER PUMP (WHEREAS WE USUALLY USE ANOTHER TYPE OF SYRINGE, 60 ML CAPACITY). IN THIS DIFFUSER FILLING SITUATION, WE PLACE THE PISTON AT THE BOTTOM AGAINST THE BENCH AND PRESS UP AND DOWN TO FILL THE DIFFUSER. THIS CAUSED THE PRODUCT TO FLOW BACK THROUGH THE PISTON.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHEN FILLING DIFFUSER PUMP WITH SYRINGE, MEDICATION LEAKED WITH A BD SYRINGE 50 ML PERFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THIS SYRINGE WAS USED TO FILL A CHEMOTHERAPY DIFFUSER PUMP (WHEREAS WE USUALLY USE ANOTHER TYPE OF SYRINGE, 60 ML CAPACITY). IN THIS DIFFUSER FILLING SITUATION, WE PLACE THE PISTON AT THE BOTTOM AGAINST THE BENCH AND PRESS UP AND DOWN TO FILL THE DIFFUSER. THIS CAUSED THE PRODUCT TO FLOW BACK THROUGH THE PISTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907759 BD SYRINGE 50ML PERFUSION PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1902205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other