BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7179715 · Received January 10, 2018

    Report

    Report Number
    1213809-2017-00433
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 20, 2017
    Report Date
    January 22, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SUMMARY: DHR REVIEW FOR BATCH 708299: MANUFACTURING DATES: 04/04/2017 TO 04/05/2017. BATCH QUANTITY WAS 302,400. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. A WATER LEAK WAS RECORDED IN ONE OF THE MOLDING MACHINES MANUFACTURING THE BARRELS FOR THIS PRODUCT. THE MACHINE WAS DOWN FOR APPROXIMATELY 4 HOURS TO ADDRESS THE PROBLEM BEFORE PRODUCTION RESUMED. BATCH 7082993 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: THREE PHOTOS WERE RECEIVED BY BD CANAAN DEPICTING PARTS OF A 1ML LL PRODUCT FROM A REPORTED BATCH #7082993. TWO DEFECTS COULD BE OBSERVED IN THE PHOTOS. FIRST DEFECT IS NUMEROUS SMALL BLACK EMBEDDED FM IN THE BARREL WALLS. THIS IS LIKELY OVER PROCESSED PLASTIC DUE TO ELEVATED TEMPERATURE 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. THE SECOND DEFECT OBSERVED IS SEVERAL APPARENTLY EMBEDDED SPOTS OF CLUSTERED SMALL BUBBLES IN THE PLASTIC. THE DEFECT WAS DIFFICULT TO IDENTIFY WITHOUT THE PHYSICAL SAMPLE. THE DEFECT IS POSSIBLY DUE TO THE PRESENCE OF MOISTURE IN THE RESIN DURING THE TIME OF THE MOLDING PROCESS, SPECIFICALLY AT STARTUP. IF MOISTURE WAS PRESENT IN THE RESIN, IT WOULD GET VAPORIZED INSIDE THE MOLD AND THE DEFECT OBSERVED COULD OCCUR. HOWEVER, TO CONFIRM THE NATURE AND ROOT CAUSE OF THE DEFECT, THE PHYSICAL SAMPLE WOULD NEED TO BE EVALUATED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. FIRST DEFECT IS NUMEROUS SMALL BLACK EMBEDDED FM IN THE BARREL WALLS. THIS IS LIKELY OVER PROCESSED PLASTIC DUE TO ELEVATED TEMPERATURE INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. THE SECOND DEFECT OBSERVED IS SEVERAL APPARENTLY EMBEDDED SPOTS OF CLUSTERED SMALL BUBBLES IN THE PLASTIC. TO CONFIRM THE NATURE AND ROOT CAUSE OF THE DEFECT, THE PHYSICAL SAMPLE WOULD NEED TO BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, A BD LUER-LOK¿ DISPOSABLE SYRINGE WAS FOUND WITH "WHITE PRECIPITATE, ON LINEAR OF THE WALL OF SYRINGE AND TWO ROUND WHITE PRECIPITATED IN THE SOLUTION." THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24145 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7082993 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other