BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 22621452 · Received July 26, 2025

    Report

    Report Number
    9610048-2025-00095
    Event Type
    Malfunction
    Date Received
    July 26, 2025
    Date of Event
    June 26, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883110
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 4183702. 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. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THEM. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. 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 NEEDLE BREAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PUNCTURE CANNULA BREAKS OR BENDS DURING PUNCTURE, RESULTING IN A MULTI-PUNCTURE TO THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 07/28/2025. IS THERE ANY PATIENT IMPACT, IF YES, PLEASE EXPLAIN IN DETAILS? A: PATIENT WITH POLYURETHANE PERFORATION MULTIPUNCTURE. CAN YOU PLEASE SHARE THE BATCH NUMBER OF THIS REPORTED EVENT? A: LOT 4183702. CAN YOU PLEASE CONFIRM THE DATE OF EVENT? A: DIFFERENT ACCORDING TO COMPLAINTS. CAN YOU PLEASE CONFIRM THE AFFECTED QUANTITY? A: (B)(4) UNITS PURCHASED FROM THE MEASURE. IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? IF YES, PLEASE ANSWER THE BELOW. A: NO. A SYNCHRONOUS MEETING WAS HELD WITH SPECIALIST CLARIFYING PROBLEMS WITH PUNCTURE TECHNIQUE. ADDITIONAL INFORMATION RECEIVED ON 08/12/2025. 1. (B)(4) IS TOTAL PURCHASED. CAN YOU PLEASE CONFIRM THE EXACT NUMBER OF DEFECTIVE ITEMS? A: ALONG WITH GREETINGS, WE COULD NOT ESTIMATE THE QUANTITY, SINCE THEY HAVE INDICATED TO USE MORE THAN ONE WAY PER PATIENT, UP TO 6 IN SOME CASES. YOU COULD CONSIDER 50% OF THE INPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2632588 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. UNKNOWN 00382903883110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown