BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 6988977 · Received October 30, 2017

    Report

    Report Number
    1213809-2017-00220
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 5, 2017
    Report Date
    January 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 7212743 (P/N 309657): MANUFACTURING DATES: 08/23/2017 ¿ 08/24/2017. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7212743 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE UN-SEALED 3ML PACKAGED SYRINGE WAS RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7212743 (P/N 309657). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE TWO PIECES OF LIGHT BROWN EMBEDDED FOREIGN MATTER IN THE BARREL WALL, ONE OF WHICH WAS LARGER THAN LEVEL 3 IN SIZE ¿ A REJECTABLE CONDITION AT BD (B)(4). 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. CONCLUSION: BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. 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. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP WAS FOUND BEFORE USE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765915 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7212743 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other