BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8560602 · Received April 29, 2019

    Report

    Report Number
    3003152976-2019-00291
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 17, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAMPLE WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, OBSERVING A BROWN FOREIGN MATTER INSIDE THE SYRINGE TIP. USING MAGNIFICATION TO FURTHER EVALUATE, THE SUBSTANCE WAS IDENTIFIED TO BE DIRT WHICH COULD BE REMOVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON REPORTED LOT 1902221 AND NO QUALITY ISSUES WERE FOUND DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. EQUIPMENT WITHIN THE MANUFACTURING LINE IS REGULARLY CLEANED ACCORDING TO PROCEDURE TO PREVENT DEFECTS SUCH AS THIS INCIDENT. VISUAL AND FUNCTIONAL INSPECTIONS ARE CONDUCTED THROUGHOUT THE ENTIRE MANUFACTURING PROCESS TO REDUCE ANY DEFECTS WITH OUR PRODUCT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. A PROJECT HAS BEEN INITIATED TO REDUCE ISSUES INVOLVING FOREIGN MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE WAS FOREIGN MATTER IN THE PACKAGE ON THE LUER CONNECTION "WHEN OPENING THE STERILE SYRINGE, PRESENCE OF BROWN SPOTS AND DUST ON THE LUER CONNECTION". FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WHEN OPENING THE STERILE SYRINGE, PRESENCE OF BROWN SPOTS AND DUST ON THE LUER CONNECTION".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE WAS FOREIGN MATTER IN THE PACKAGE ON THE LUER CONNECTION "WHEN OPENING THE STERILE SYRINGE, PRESENCE OF BROWN SPOTS AND DUST ON THE LUER CONNECTION". FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN OPENING THE STERILE SYRINGE, PRESENCE OF BROWN SPOTS AND DUST ON THE LUER CONNECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356443 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE SYRINGE WITH NEEDLE FMI BECTON DICKINSON, S.A. 1902221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other