BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 16502905 · Received March 8, 2023

    Report

    Report Number
    9610048-2023-00013
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 10, 2023
    Report Date
    April 18, 2023
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 38183414 AND LOT NUMBER 2070987. 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 SAMPLES WERE NOT AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE TWO (2) IMAGES PROVIDED ONLY SHOW THE UNIT PACKAGING INFORMATION. BASED ON THE LIMITED INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKAGE OCCURRED AT THE CONNECTOR. THERE WAS NOR REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AFTER PUNCTURE, A LEAK WAS OBSERVED BETWEEN THE PINK CONNECTOR AND THE SILICONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKAGE OCCURRED AT THE CONNECTOR. THERE WAS NOR REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AFTER PUNCTURE, A LEAK WAS OBSERVED BETWEEN THE PINK CONNECTOR AND THE SILICONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122365 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381834 2070987 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown