BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY

    MDR report key: 6838961 · Received September 1, 2017

    Report

    Report Number
    9610847-2017-00061
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    August 4, 2017
    Report Date
    January 9, 2018
    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

    RESULTS: DHR REVIEW FOR MATERIAL 8000952 BATCH 6341563: 14 BULK PACKAGING INSPECTIONS WERE PERFORMED ON 700 SYRINGES AND ZERO DEFECTS WERE FOUND. 12 PRINT/ASSEMBLY INSPECTIONS WERE PERFORMED ON 600 SYRINGES AND ZERO DEFECTS WERE FOUND. NO QN'S FOUND IN THE DHR. PHOTOS CONFIRM THAT BLACK DOTS WERE FOUND NEAR THE TIP. IT'S POSSIBLE THAT THE BLACK SPECS WERE BURNT PIECES OF POLYPROPYLENE THAT WERE IMBEDDED DURING THE MOLDING PROCESS. ROOT CAUSE: ROOT CAUSE FOR CARDBOARD UNDETERMINED. BLACK DOTS: IT'S POSSIBLE THAT THE BLACK SPECS WERE BURNT PIECES OF POLYPROPYLENE THAT WERE IMBEDDED DURING THE MOLDING PROCESS. BASED ON EVALUATION OF THE SEVERITY AND FREQUENCY OF THE REPORTED INCIDENT, IT IS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 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: 36020 PCS. 60ML SYRINGE LOT (P/N 8000952) USED IS 6341563 FOR LOT 7093577. NO QN¿S WERE FOUND FOR LOT 6341563 IN SAP AND INCOMING INSPECTION RECORDS. 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. BASED ON THE DESCRIPTION RECEIVED THE FOREIGN MATTER (SEVERAL BLACK SPOTS ON TOP PORTION OF BARREL NEAR TIP AND A PIECE OF CARDBOARD IN BARREL OF SYRINGE). THE BLACK SPECKS ARE CAUSED DURING THE SUPPLIER MOLDING PROCESS. THE PIECE OF CARDBOARD IN SYRINGE MAYBE POTENTIALLY CAUSED DURING THE PACKAGING PROCESS. ONE DEBRIS FROM THE PACKAGING MAY FALL INTO THE SYRINGE. BLACK SPOT: NOT ABLE TO INVESTIGATE THE ROOT CAUSE SINCE THIS DEFECT IS CAUSED IN THE SUPPLIER MOLDING PROCESS. PIECE OF CARDBOARD INSIDE THE BARREL OF SYRINGE: THIS DEFECT MAY BE CAUSED DURING THE PACKAGING PROCESS. A PIECE OF CARDBOARD COULD FALL INTO THE SYRINGE THROUGH THE OPENING BETWEEN THE PLUNGER AND THE BARREL. THE SYRINGE IS NOT ASSEMBLED IN (B)(6) FACILITY. QUALITY ALERT# 94 AND # 98 WERE ISSUED TO ALERT ALL OPERATORS FOR THE ABOVE DESCRIBED DEFECTS. A CONCLUSION IS NOT YET AVAILABLE AS THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK SPOTS AND CARDBOARD WERE FOUND IN THE SYRINGE OF A BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619539 BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY CONVENTIONAL SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7093577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other