BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY

    MDR report key: 6772998 · Received August 8, 2017

    Report

    Report Number
    9610847-2017-00056
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 13, 2017
    Report Date
    September 7, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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. UDI#: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 7093575 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. DURING THE MANUFACTURE OF THIS PRODUCT, 100% VISUAL INSPECTION IS PERFORMED BEFORE PACKAGING THE PRODUCT IN DISPENSERS LOOKING FOR LOOSE FOREIGN MATERIAL AND EMBEDDED FOREIGN MATERIAL IN COMPONENTS OR INSIDE OF THE PACKAGE. DURING THE 100% INSPECTION EMBEDDED FOREIGN MATERIAL WAS NOT DETECTED BY OUR OPERATORS. THE MANUFACTURING PROCESS WAS REVIEWED AND NO POTENTIAL FAILURES WERE IDENTIFIED SINCE ONLY SYRINGE PACKAGING PROCESS IS PERFORMED AT (B)(6) FACILITY. NOT ABLE TO INVESTIGATE THE ROOT CAUSE SINCE THE SAMPLES RECEIVED WERE NOT CAUSED IN NOGALES PROCESS. HOWEVER, THE DEFECT DESCRIPTION FOR THE SAMPLES RECEIVED SHOW THAT ALL OF THIS FOREIGN MATERIAL DEFECTS WERE POTENTIALLY CAUSED IN THE MOLDING PROCESS PERFORMED AT THE SUPPLIER SITE. THE SYRINGE IS NOT ASSEMBLED IN (B)(6) FACILITY. NO CAPA WILL BE ISSUED, DUE THAT A RISK ASSESSMENT WAS PERFORMED OBTAINING THE RESULT OF SEVERITY S1 AND DUE TO WITHOUT SAMPLES THE DEFECT CANNOT BE CONFIRMED. THE SAMPLES HAVE BEEN FORWARDED TO THE MANUFACTURING SITE IN COLUMBUS, NE FOR A SECONDARY EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SECOND SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: FIVE SAMPLES WERE RECEIVED, 3 HAD FOREIGN MATTER EMBEDDED IN THE PLASTIC OF THE SYRINGE, TWO HAD INK DOTS ON THE EXTERIOR OF THE SYRINGE BARREL. EMBEDDED FOREIGN MATTER IS TYPICALLY CAUSED WHEN THE MOLD PRESS STARTS IN THE UP POSITION. AS THE MOLD WARMS UP, PARTICULATE BREAKS AWAY FROM THE PRESS SCREW AND THE MOLD INTERIOR. WHEN A PRESS STARTS UP, THE PRODUCT IS INSPECTED AND SCRAPPED IF IT STILL HAS FOREIGN MATTER FROM STARTUP. INK MARKINGS ARE A SPOT SEEN ON THE SYRINGE FROM THE INK GRADUATION SCALED PRINTED ON THE SYRINGE. IT IS POSSIBLE THAT INK FROM THE GRADUATION SCALE CAN TRANSFER FROM SYRINGE TO SYRINGE DURING PACKAGING AND SHIPPING. ALTHOUGH THE CUSTOMER'S REPORTED DEFECT WAS CONFIRMED, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. CAPA (B)(4) WAS INITIATED FOR THIS ISSUE TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS AND REMEDIATION PLAN TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON SEVERAL SYRINGES FROM THE BD" SYRINGE 60CC LUER-LOK" CONVENIENCE TRAY. THE SYRINGES WERE NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553257 BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7093575

    Patients

    Seq Age Sex Outcome Treatment
    1 Other