BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY

    MDR report key: 6879247 · Received September 20, 2017

    Report

    Report Number
    9610847-2017-00080
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 23, 2017
    Report Date
    December 4, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED AND WILL BE EVALUATED. INVESTIGATION: RETURN SAMPLES RECEIVED: YES, PHOTO RECEIVED. RETURN SAMPLE SHOWED: PHOTO SHOWED REPORTED DEFECT: YES. DHR/BHR REVIEW: NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 7122878 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. LOT NO #: 7122878 CATALOG #: 309680 QUANTITY PRODUCED: (B)(4) PCS. THE 60ML SYRINGE LOTS (P/N 8000952) USED ARE 7019658 & 7019656 FOR LOT 7122878. NO QN¿S WERE FOUND FOR LOTS 7019658 & 7019656 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/LOOSE 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)(4) FACILITY. CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. INVESTIGATION COMMENTS: NOT ABLE TO CONFIRM THE REPORTED FAILURE MODE SINCE NO SAMPLES WERE RECEIVED SHOWING THE ABOVE DESCRIBED DEFECT. BASED ON THE DESCRIPTION RECEIVED THE FOREIGN MATTER (FINE BLACK CONTAMINANT INSIDE OF THE SYRINGE BARREL) IS LIKELY CAUSED DURING THE SUPPLIER MOLDING PROCESS AND THE BLACKISH COLOR IS OBTAINED AFTER THE STERILIZATION PROCESS. PRODUCT WITHIN SPECIFICATION? YES, NO. ROOT CAUSE: NOT ABLE TO INVESTIGATE THE ROOT CAUSE SINCE THIS ABOVE REPORTED DEFECT IS CAUSED IN THE SUPPLIER MOLDING PROCESS. THE SYRINGE IS NOT ASSEMBLED IN (B)(4) FACILITY. (B)(4).

    Additional Manufacturer Narrative · 1

    SAMPLES WERE NOT RETURNED. INVESTIGATION PER AVAILABLE PHOTO. 7122878-CONVERT-7019658-4/26/17-AT BULK PROCESS THERE WERE 13 INSPECTIONS ON (B)(4) PARTS AND AT PRINT/ASSY THERE WERE 12 INSPECTIONS ON (B)(4) PARTS WITH ZERO DEFECTS FOUND. 7122878-CONVERT-7019656-4/26/17-AT BULK PROCESS THERE WERE 12 INSPECTIONS ON (B)(4) PARTS AND 13 INSPECTIONS ON (B)(4) PARTS WITH ZERO DEFECTS FOUND. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. PICTURE DID REVEAL FM IN SYRINGE. BASED ON THE INVESTIGATION RESULTS TO DATE, ROOT CAUSE COULD NOT BE CONFIRMED. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, THERE WAS FINE BLACK FOREIGN MATTER INSIDE OF SYRINGE BARREL OF THE BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658510 BD¿ SYRINGE 60CC LUER-LOK¿ CONVENIENCE TRAY SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7122878

    Patients

    Seq Age Sex Outcome Treatment
    1 Other