BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N

    MDR report key: 18967932 · Received March 25, 2024

    Report

    Report Number
    9610048-2024-00034
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    February 29, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883424
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: REVIEW OF THE INFORMATION PROVIDED, AND THE INVESTIGATION RESULTS INDICATES THAT THIS CATHETER WAS UNUSABLE AT THE TIME THAT THE INDIVIDUAL PACKAGE WAS OPENED. THIS EVENT IS NOT MDR REPORTABLE; CANCEL MDR.

    Additional Manufacturer Narrative · 0

    E. STREET ADDRESS LONGER THAN ALLOWABLE: (B)(6). H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38834214 AND LOT NUMBER 3082690. 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 RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, THE CATHETER TIP WAS OBSERVED DEFECTIVE. IT APPEARS THAT THE CATHETER UNIT IS PUSHED OUT FROM THE NEEDLE UNIT AND THAT THE CATHETER TIP IS BENT. AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. THERE ARE CURRENT CONTROLS IN PLACE FOR OUTGOING AND IN-PROCESS INSPECTIONS FOR CATHETER TUBING DAMAGE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE-N CATHETER TIP IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUES TO ENGLISH: CATHETER HAS DAMAGED TIP.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525391 BD INSYTE-N PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3082690 00382903883424

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown