BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER 20GA 1.88IN

    MDR report key: 9526991 · Received December 27, 2019

    Report

    Report Number
    9610048-2019-00355
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 5, 2019
    Report Date
    March 12, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811374
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6.INVESTIGATION SUMMARY BD RECEIVED A 20 GAUGE ANGIOCATH UNIT FROM LOT 8050698 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED A SPECK OF FOREIGN MATTER (FM) IN THE NEEDLE CAP. THE SPECK WAS COLLECTED AND SENT FOR FTIR ANALYSIS. THE ANALYSIS DETERMINED THAT THE FM WAS A MIXTURE OF CELLULOSE AND SILICONE. SILICONE WAS USED DURING THE MANUFACTURING AND TIPPING PROCESS AND CELLULOSE MOST LIKELY CAME FROM THE PACKAGING PROCESS. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT CAME FROM EXCESS SILICONE ON THE TIP COLLECTING A PIECE OF PACKAGING MATERIAL OR DEBRIS. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD ANGIOCATH¿ IV CATHETER 20GA 1.88IN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THERE WAS COTTON WOOL IN THE NEEDLE CAP. THE CUSTOMER WANTED TO GET A WRITTEN TEST RESULT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD ANGIOCATH¿ IV CATHETER 20GA 1.88IN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THERE WAS COTTON WOOL IN THE NEEDLE CAP. THE CUSTOMER WANTED TO GET A WRITTEN TEST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322851 BD ANGIOCATH¿ IV CATHETER 20GA 1.88IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381137 8050698 30382903811374

    Patients

    Seq Age Sex Outcome Treatment
    1 Other