BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY

    MDR report key: 6894744 · Received September 26, 2017

    Report

    Report Number
    9610847-2017-00082
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 31, 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

    INVESTIGATION ROOT CAUSE ANALYSIS RESULTS. SEVERITY: S1. SAMPLES WERE DECONTAMINATED BY: N/A. NO SAMPLES WERE RECEIVED. PHOTO SHOWED REPORTED DEFECT: YES. RETURNED MATERIAL SHOWED REPORTED DEFECT: N/A. NO RETENTION SAMPLES WERE KEPT FOR THIS PRODUCT. COMPLAINT HISTORY CHECK FOR LOT 7093577 WAS VERIFIED AND NO DISCREPANCIES WERE FOUND ABOUT THE ABOVE DESCRIBED PROBLEM. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7093577. NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 7093577 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. THE MANUFACTURING PROCESS WAS REVIEWED AND NO POTENTIAL FAILURES WERE IDENTIFIED SINCE ONLY SYRINGE PACKAGING PROCESS IS PERFORMED AT NOGALES FACILITY. BASED ON THE DESCRIPTION RECEIVED THE FOREIGN MATTER (PARTICULATE-CHARRED PLASTIC IN THE SYRINGE. THIS FAILURE MODE IS CAUSED DURING THE SUPPLIER MOLDING PROCESS. PICTURES WILL BE SUBMITTED TO NOGALES INCOMING INSPECTION TO ALERT THE SUPPLIER. PRODUCT WITHIN SPECIFICATION?-YES ROOT CAUSE: N/A- NOT ABLE TO INVESTIGATE THE ROOT CAUSE SINCE THE SAMPLES RECEIVED WERE NOT CAUSED IN NOGALES PROCESS. HOWEVER, THE DEFECT DESCRIPTION FOR THE SAMPLE RECEIVED SHOWS THAT THE ABOVE DESCRIPTION FOR THE SAMPLE RECEIVED SHOWS THAT THE ABOVE DESCRIBED FOREIGN MATERIAL DEFECT WAS POTENTIALLY CAUSED IN THE MOLDING PROCESS PERFORMED AT THE SUPPLIER SITE. THE SYRINGE IS NOT ASSEMBLES IN THE NOGALES FACILITY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY HAD A CHARRED PIECE OF PLASTIC INSIDE THE SYRINGE BARREL MAKING THE PRODUCT INOPERABLE. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675911 BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7093577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other