BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50 ML BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 8578831 · Received May 3, 2019

    Report

    Report Number
    3003152976-2019-00301
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 20, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: FIFTEEN SAMPLES AND MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, PARTICLES WERE OBSERVED INSIDE THE SYRINGE. USING MAGNIFICATION TO FURTHER EVALUATE, THE PARTICLES WERE IDENTIFIED TO BE FIBERS OF POLYPROPYLENE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1902356, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. EQUIPMENT WITHIN THE MANUFACTURING LINE IS REGULARLY CLEANED ACCORDING TO PROCEDURE TO PREVENT DEFECTS SUCH AS THIS INCIDENT. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THIS INSTANCE OCCURRED DURING THE TRANSPORT PROCESS OF PIECES WITHIN THE MANUFACTURING AREA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER IN SYRINGES WITH A 50 ML BD PLASTIPAK¿ LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WHEN CHECKING THESE BULK SYRINGES, WE FOUND UNKNOWN PARTICLES IN A NUMBER OF SYRINGES: 15 FROM 50 SYRINGES HAD A FOREIGN MATTER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER IN SYRINGES WITH A 50 ML BD PLASTIPAK¿ LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN CHECKING THESE BULK SYRINGES, WE FOUND UNKNOWN PARTICLES IN A NUMBER OF SYRINGES: 15 FROM 50 SYRINGES HAD A FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372419 50 ML BD PLASTIPAK LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1902356

    Patients

    Seq Age Sex Outcome Treatment
    1 Other