BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 14406969 · Received May 16, 2022

    Report

    Report Number
    9610825-2022-00161
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 24, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046963318178
    PMA / PMN Number
    K020785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). NO SAMPLE RECEIVED AND NO PICTURE PROVIDED FOR EVALUATION. REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 21H25G8245 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION AS NO SAMPLE WAS RECEIVED, FURTHER EVALUATION WAS NOT POSSIBLE. THE COMPLAINT BATCH SHOWS NO ABNORMALITY. SHOULD SAMPLE IS RECEIVED, WE WILL REOPEN THIS NOTIFICATION FOR RE-EVALAUTION. MEANWHILE, COMPLAINT IS ADDED INTO THE STATISTIC FOR TREND ANALYSIS OF THIS PRODUCT LINE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER WAS USING 4252520-02 INTROCAN SAFETY CATHETERS. UPON DRAWING THE STYLET OUT OF THE CATHETER, THE NEEDLE WAS EXPOSED, THE SAFETY CLIP DID NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746102 INTROCAN SAFETY® CATHETER,INTRAVASCULAR FOZ B. BRAUN MELSUNGEN AG 4252520-02 21H25G8245 04046963318178

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown