BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY

    MDR report key: 6859029 · Received September 12, 2017

    Report

    Report Number
    9610847-2017-00071
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 18, 2017
    Report Date
    August 28, 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

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION: RETURN SAMPLES RECEIVED: YES, PHOTO RECEIVED. PROBLEM STATEMENT: IT WAS REPORTED THAT THE CUSTOMER FOUND PARTS WITH BLACK SMUDGE NEAR LUER LOCK, BLACK SPECK EMBEDDED IN PLASTIC. CATALOG 309680. LOT 7093577. RETURN SAMPLE SHOWED: PHOTO SHOWED REPORTED DEFECT - YES RETURNED MATERIAL SHOWED REPORTED DEFECT - YES DHR/BHR REVIEW: 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) PCS. 60ML SYRINGE LOT (P/N 8000952) USED IS (B)(4) 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. MANUFACTURING REVIEW: THE MANUFACTURING PROCESS WAS REVIEWED AND NO POTENTIAL FAILURES WERE IDENTIFIED SINCE ONLY SYRINGE PACKAGING PROCESS IS PERFORMED AT (B)(6) FACILITY. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE INVESTIGATION COMMENTS: BASED ON THE DESCRIPTION RECEIVED THE FOREIGN MATTER (BLACK SMUDGE NEAR LUER LOCK, BLACK SPECK EMBEDDED IN PLASTIC). THIS FAILURE MODE IS CAUSED DURING THE SUPPLIER MOLDING PROCESS. PICTURES AND SAMPLES WILL BE SUBMITTED TO THE SUPPLIER FOR FURTHER ANALYSIS. ROOT CAUSE: N/A. NOT ABLE TO INVESTIGATE THE ROOT CAUSE SINCE THE ABOVE DESCRIBED DEFECTS CAN¿T BE DUPLICATED IN THE (B)(4) PROCESS. HOWEVER, FOR THE DEFECT DESCRIPTION THIS MAY BE CAUSED IN THE PROCESS PERFORMED AT THE SUPPLIER SITE ((B)(4)). THE SYRINGE IS NOT ASSEMBLED IN (B)(4) FACILITY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY, BEFORE USE. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637758 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