BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOCK SYRINGE

    MDR report key: 7636558 · Received June 25, 2018

    Report

    Report Number
    3003152976-2018-00250
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 24, 2018
    Report Date
    June 27, 2018
    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
    FI
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ONE UNUSED SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE SAMPLE, THE STOPPER WAS OBSERVED DISCONNECTED FROM THE PLUNGER. NO DAMAGES OR MOLDING DEFECTS WERE OBSERVED TO THE PLUNGER ROD THAT COULD HAVE CAUSED THIS DEFECT. A DEVICE HISTORY RECORD REVIEW OF LOT 1802268 REVEALED A NON-CONFORMANCE DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT MAY HAVE CONTRIBUTED TO THE OBSERVED DEFECT. DURING MANUFACTURING, A FAILURE WAS DETECTED IN THE ASSEMBLY PROCESS OF THE STOPPERS AND PLUNGERS. THE STOPPERS WERE INCORRECTLY ASSEMBLED AND ONCE THE PLUNGERS WERE MOVED, THE STOPPER WOULD COMPLETELY DISASSEMBLE. ONCE DETECTED, DEFECTIVE SAMPLES WERE REJECTED AND THE MECHANICAL TEAM REPAIRED THE FAILURES. THE OBSERVED DEFECT WITHIN THE RETURNED SAMPLE HAS BEEN DETERMINED A RESULT OF THIS NON-CONFORMANCE. PROPER MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THIS INCIDENT. BASED ON SEVERITY AND OCCURRENCE NO FORMAL CAPA IS REQUIRED ACCORDING TO INTERNAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE INNER PORTION BD PLASTIPAK¿ LUER-LOCK SYRINGE IS BROKEN. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475286 BD PLASTIPAK¿ LUER-LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802268

    Patients

    Seq Age Sex Outcome Treatment
    1 Other