BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH PNK 20GA X 1.88IN

    MDR report key: 21351482 · Received February 10, 2025

    Report

    Report Number
    9610048-2025-00009
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 24, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903811373
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 381137 AND LOT NUMBER 4113785. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, FOREIGN MATTER WITH THE APPEARANCE OF DIRT WAS OBSERVED IN THE MIDDLE OF THE CATHETER. HOWEVER, FOR A DETAILED ANALYSIS AND IDENTIFICATION OF THE FOREIGN MATTER, THE PHYSICAL SAMPLE WOULD BE NECESSARY. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM AN EXCESSIVE AMOUNT OF SILICONE DURING THE SILICONIZATION PROCESS OF THE CATHETER. IT SHOULD BE NOTED THAT SILICONE DOES NOT CAUSE HARM TO THE PATIENT/USER AND IS USED TO HELP SLIDE THE CATHETER DURING VENIPUNCTURE. IT IS ALSO POSSIBLE THAT THE FOREIGN MATTER IS RELATED TO DIRT ON THE WALLS OF THE MACHINE IN THE GRIND FEEDING AREA. DURING THE FEEDING OF THE CATHETER GRIDS, WHEN THE MACHINE VIBRATES (A NORMAL PROCESS OF THE MACHINE) THE CATHETERS MAY TOUCH THE WALL AND IF THE WALL IS NOT PROPERLY CLEANED, DIRT MAY GENERATE ON THE CATHETER. THE ASSOCIATES IN THE APPLICABLE MANUFACTURING AREAS WERE MADE AWARE OF THIS INCIDENT AND THE IMPORTANCE OF PROPER CLEANING OF THE MACHINE TO PREVENT ANY DEFECTS LIKE THIS FROM OCCURRING. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ANGIOCATH PNK 20GA X 1.88IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN BODY STICK ON NEEDLE. ADDITIONAL INFORMATION PROVIDED: 1. COULD YOU PLEASE PROVIDE THE DATE OF THE EVENT? 24 JAN 2025. 2. COULD YOU PLEASE PROVIDE THE NUMBER OF OCCURRENCES? 1. 3. COULD YOU PLEASE PROVIDE THE SAMPLE PICTURE? 4. KINDLY CONFIRM WAS THERE ANY PHYSICAL SAMPLE AVAILABLE? IF YES, PLEASE PROVIDE SAMPLE TRACKING DETAILS. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872136 BD ANGIOCATH PNK 20GA X 1.88IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4113785 00382903811373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown