BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOCATH PNK 20GA X 1.16IN

    MDR report key: 10687970 · Received October 15, 2020

    Report

    Report Number
    9610048-2020-00143
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 28, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811343
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD RECEIVED A 20 GAUGE ANGIOCATH UNIT FROM LOT 7241836 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 PIECE OF FOREIGN MATTER INSIDE THE PACKAGE. THE PIECE OF FOREIGN MATTER WAS INSPECTED AND DETERMINED TO BE PIECE OF CARDBOARD. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS AN OPERATOR ERROR THAT OCCURRED DURING THE PACKAGING PROCESS. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A TRAINING WAS ISSUED TO ALL PACKAGING OPERATORS TO RAISE AWARENESS OF THIS ISSUE AND PREVENT RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE ANGIOCATH PNK 20GA X 1.16IN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "381134, BATCH: 7241836, THERE ARE FOREIGN OBJECTS IN THIS PRODUCT."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE ANGIOCATH PNK 20GA X 1.16IN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(4) TO ENGLISH: "381134, BATCH: 7241836, THERE ARE FOREIGN OBJECTS IN THIS PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152619 ANGIOCATH PNK 20GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381134 7241836 30382903811343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other