BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 3 ML BD LUER-LOK¿ BLUNT FILL NEEDLE

    MDR report key: 7314957 · Received March 5, 2018

    Report

    Report Number
    1213809-2018-00143
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    February 8, 2018
    Report Date
    March 29, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903050605
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: ONE OPEN 3ML PACKAGED SYRINGE AND ONE EMPTY SYRINGE PACKAGE WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7093570 (P/N 305060). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE LIGHT BROWN EMBEDDED FM IN THE BARREL WALL. THE FM CONSISTS OF MULTIPLE EMBEDDED SPOTS OBSERVED BETWEEN APPROXIMATELY THE BARREL FLANGE AND 1 1/2 ML GRAD LINE. THE FM IS LARGER THAN LEVEL 3 IN SIZE, WHICH IS A REJECTABLE AT BD CANAAN. THE BARREL WAS CONFIRMED TO BE FROM MOLD C - 233 CAVITY 48. THE EMBEDDED FM IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. PER PROCEDURE, AFTER START UP, ALL MOLDED PARTS ARE SCRAPPED UNTIL NO DEGRADED PLASTIC IS OBSERVED. IF THIS IS NOT PERFORMED THOROUGHLY A PIECE WITH THIS CONDITION CAN GET THROUGH. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. DHR REVIEW FOR BATCH 7093570 (P/N 305060): MANUFACTURING DATES: 04/17/2017 TO 04/18/2017. BATCH QUANTITY WAS (B)(4). PRINTING AND ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7093570 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER THAT A ¿BROWN STAIN¿ WAS FOUND INSIDE A BD¿ 3 ML BD LUER-LOK¿ BLUNT FILL NEEDLE AS CONTRAST WAS BEING DRAWN INTO THE SYRINGE. THERE WAS NO EXPOSURE, INJURY OR MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155672 BD¿ 3 ML BD LUER-LOK¿ BLUNT FILL NEEDLE HYPODERMIC SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 7093570 30382903050605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other