BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY ® 2

    MDR report key: 20205502 · Received September 12, 2024

    Report

    Report Number
    9610825-2024-00720
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Report Date
    October 10, 2024
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K220756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). EVENT 1 WHILE A SAMPLE OF THE INTROCAN SAFETY 2 WL PUR M 24GX19MM - US WAS NOT AVAILABLE, A BD Q-STYLE EXTENSION SET WAS SUBMITTED TO THE MANUFACTURER FOR EVALUATION. IT IS NOTED THAT THE BD Q-STYLE EXTENSION SET IS NOT A B. BRAUN MEDICAL INC. PRODUCT. THROUGH MICROSCOPIC EXAMINATION, NO DAMAGES WERE OBSERVED ON THE LUER LOCK CONNECTOR OF THE EXTENSION SET. A SIMULATION WAS PERFORMED ON A FRESH INTROCAN SAFETY 2-M G24 CATHETER HUB SAMPLE AND WAS CONNECTED TO THE RETURNED BD Q-STYLE EXTENSION SET AND FLUSHED WITH RED DYE WATER TO CHECK FOR LEAKAGE AT THE LUER CONNECTION AREA. NO LEAKAGE WAS OBSERVED FROM THE LUER CONNECTION BETWEEN EXTENSION SET AND THE CATHETER HUB. FURTHER TESTS WAS ALSO CONDUCTED ON A FRESH SAMPLE OF AN INTROCAN AND INTROCAN SAFETY 3; NO LEAKAGE WAS OBSERVED. BASED ON THE SIMULATION, IT WAS CONFIRMED THAT THE B. BRAUN IV CATHETERS ARE COMPATIBLE WITH THE RETURNED BD Q-STYLE EXTENSION SET AS NO LEAKAGE WAS OBSERVED BETWEEN THE CONNECTORS. BASED ON THE INVESTIGATION, THE REPORTED DEFECT WAS NOT ABLE TO BE OBSERVED OR REPLICATED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: CATHETER LEAKING AT CONNECTION TO EXTENSION SET. DETAILED INQUIRY DESCRIPTION: IV CATHETER IS LEAKING AT CONNECTION SITE TO EXTENSION SET. EXTENSION SET IS BD Q-SYTE, NOT A BBRAUN PRODUCT. CUSTOMER REPORTED THAT THE IV HUB IS NOT CONNECTING WELL OR IT IS WORKING ITS WAY LOOSE, ALLOWING FLUID TO LEAK OUT UNDER THE IV DRESSING DURING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505457 INTROCAN SAFETY ® 2 CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown