BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18G X 1.16IN (1.3 X 30 MM) ANGIOCATH

    MDR report key: 9355500 · Received November 21, 2019

    Report

    Report Number
    9610048-2019-00332
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811442
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED AN 18 GAUGE ANGIOCATH UNIT FROM LOT 7173829 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 SILICONE VISIBLE ON THE UNIT. SILICONE WAS USED DURING THE MANUFACTURING PROCESS TO AID WITH VENIPUNCTURE AND THREADING. IT HAS BEEN CONFIRMED THAT SILICONE WILL NOT CAUSE HARM TO THE USER. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THE EXCESS SILICONE MOST LIKELY CAME FROM THE CATHETER TIPPING PROCESS AND FINAL ASSEMBLY. CAPA#450094 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 18G X 1.16IN (1.3 X 30 MM) ANGIOCATH EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE POWDER WAS ON THE CATHETER.

    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 THE 18G X 1.16IN (1.3 X 30 MM) ANGIOCATH EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE POWDER WAS ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154082 18G X 1.16IN (1.3 X 30 MM) ANGIOCATH INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7173829 30382903811442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other