BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 6792846 · Received August 14, 2017

    Report

    Report Number
    9610847-2017-00052
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 20, 2017
    Report Date
    September 6, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE RECEIVED IDENTIFIED BLACK FOREIGN MATTER ON PLUNGER ROD. BD LOT 7093577, CATALOG 309680. DHR: NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 7093577 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. LOT NO #: 7093577 CATALOG #: 309680 QUANTITY PRODUCED:(B)(4) PIECES. 60ML SYRINGE LOT (P/N 8000952) USED IS 6341563 FOR LOT 7093577. 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. 7093577-3/30/17 - AT BULK PROCESS THERE WERE 13 INSPECTIONS ON 650 PARTS AND AT PRINT/ ASSEMBLY. THERE WERE 12 INSPECTIONS ON 600 PARTS WITH ZERO DEFECTS FOUND. INVESTIGATION COMMENTS: BASED ON THE DESCRIPTION RECEIVED THE FOREIGN MATTER (SMUDGE ON THE INSIDE OF A 60 ML TRAY COVER) WAS FOUND INSIDE THE SYRINGE NOT INSIDE THE TRAY. THIS FAILURE MODE SEEMS LIKE SOME DEBRIS LEFT DURING THE SUPPLIER MOLDING PROCESS. BASED ON THE INVESTIGATION ROOT CAUSE WAS DETERMINED TO BE POSSIBLE DEGRADED PLASTIC BETWEEN MOLD PLATES THAT BREAK DOWN AND ATTACH TO PARTS OR PLUNGER ROD MAKING CONTACT WITH CONVEYOR BELTS THAT POSSIBLY HAD LOOSE FM. NON  CAPA CORRECTIVE ACTIONS  REMINDER QUALITY ALERT WAS DONE ON (B)(6) 2017 TO ALL OPERATORS THAT DURING PMS OR MACHINE REPAIRS/ UPDATES, MONITOR AND REACT TO ANY FM FOR OVER GREASING THAT MAY HAVE OCCURRED DURING DOWNTIME. FOLLOW CLEANING PROCEDURE BEFORE STARTING LINES BACK UP INTO PRODUCTION. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLACK PIECE OF PLASTIC WAS FOUND IN THE BARREL OF A 60 ML BD LUER-LOK" SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571105 60 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY CONVENTIONAL SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7093577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other