BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6835731 · Received August 31, 2017

    Report

    Report Number
    9610847-2017-00072
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    July 11, 2017
    Report Date
    October 9, 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.(B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: RETURN SAMPLES RECEIVED? YES, PHOTO RECEIVED. PHOTO SHOWED REPORTED DEFECT. NO RETENTION SAMPLES ARE KEPT FOR THIS PRODUCT. DHR: NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 7122870 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. LOT NO #: 7122870 CATALOG #: 309680 QUANTITY PRODUCED: (B)(4) PCS. 60ML SYRINGE LOTS (P/N 8000952) USED ARE 6354673 AND 7019654 FOR LOT 7122870. NO QN¿S WERE FOUND FOR LOT 6341563 AND 7019654 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. MANUFACTURING REVIEW: THE MANUFACTURING PROCESS WAS REVIEWED AND NO POTENTIAL FAILURES WERE IDENTIFIED SINCE ONLY SYRINGE PACKAGING PROCESS IS PERFORMED AT NOGALES FACILITY. CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. BASED ON THE DESCRIPTION RECEIVED THE FOREIGN MATTER (BLACK SMUDGE/FLOATING PARTICULATE MATTER INSIDE THE SYRINGE) MAYBE POTENTIALLY CAUSED DURING THE SUPPLIER MOLDING PROCESS. PRODUCT WITHIN SPECIFICATION? YES. ROOT CAUSE: BLACK SMUDGE/FLOATING PARTICULATE: NOT ABLE TO INVESTIGATE THE ROOT CAUSE SINCE THIS DEFECT IS CAUSED IN THE SUPPLIER MOLDING PROCESS. THE SYRINGE IS NOT ASSEMBLED IN NOGALES FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN MATTER PARTICULATE WAS FOUND IN THE 60 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY. IT WAS FOUND BEFORE USE WITH NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616533 60 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HYPO-POSIFLUSH-ANESTHESIA SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7122870

    Patients

    Seq Age Sex Outcome Treatment
    1 Other