BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 6636443 · Received June 13, 2017

    Report

    Report Number
    9610825-2017-00112
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 18, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046964014031
    PMA / PMN Number
    K111236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. UPON VISUAL EXAMINATION, THE SAFETY CLIP WAS NOT ACTIVATED AT THE TIP OF THE NEEDLE. THE SAFETY CLIP WAS THEN FUNCTIONALLY TESTED, AND THE CLIP FUNCTIONED AS INTENDED. IT WAS POSSIBLE TO SLIDE THE CLIP TO FIX IT ON THE TIP OF THE NEEDLE, AND WHEN PUSHED AGAINST A STRETCHED RUBBER GLOVE THE CLIP DID NOT DISENGAGE SO THE NEEDLE DID NOT PUNCTURE THE GLOVE. THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: THE SAFETY MECHANISM DID NOT COVER THE TIP OF THE NEEDLE AND ENGAGED MID-SHAFT. RN RECEIVED NEEDLE-STICK TO THE ULNAR ASPECT OF THE DISTAL PORTION OF THE RIGHT LONG FINGER WHEN CLEANING UP HER IV INSERTION SUPPLIES. NO INJURY TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016018. (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). FAILURE ANALYSIS AND INVESTIGATION RESULTS DID NOT CONFIRM THE REPORTED ISSUE. UPON RECEIPT THE ACTUAL DEVICE INVOLVED WAS VISUALLY AND FUNCTIONALLY INSPECTED. NO DAMAGES OR DEVIATIONS WERE OBSERVED WITH THE SAFETY CLIP. MULTIPLE FUNCTIONALITY TESTS WERE PERFORMED TO TEST THE SAFETY CLIP, AND IN EACH TEST THE SAFETY CLIP ENGAGED AND PERFORMED AS INTENDED. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. THE DEVICE OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418163 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG 4251129-02 16H23G8374 04046964014031

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR