BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    MDR report key: 9124957 · Received September 26, 2019

    Report

    Report Number
    3002682307-2019-00522
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 25, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301942 LOT 1811191 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. DESPITE THE FACT THAT ANY HIGH VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, THE HIGHLY CAPABLE PROCESS EMPLOYED BY BD TO PRODUCE DISCARDIT SYRINGES KEEPS PARTICULATE MATTER TO EXTREMELY LOW LEVELS THROUGH STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS. IN BD FRAGA, THE WHOLE PROCESS TO ASSEMBLY AND PACKAGE THE PRODUCT TAKES PLACE IN AN ENVIRONMENTAL CONTROLLED ROOM WHERE THE AIR IS CONTINUOUSLY FILTERED USING A HEPA FILTER SYSTEM AND THERE ARE SEVERAL STRICT MEASURES. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. ROOT CAUSE DESCRIPTION: NOT ABLE TO DETERMINE. RATIONALE: WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE S2 5ML 22GA 1-1/4IN BD (B)(6) HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: AT 8:00 A.M. ON (B)(6) 2019, THE PEDIATRIC OUTPATIENT NURSE OPENED THE PACKAGE OF 5ML SYRINGE IN THE PREPARATION OF LIQUID DISPENSATIONS, FOUND FOREIGN MATTER ON THE END OF PLUNGER ROD . NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920666 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811191

    Patients

    Seq Age Sex Outcome Treatment
    1 Other