BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2753903 · Received September 6, 2012

    Report

    Report Number
    9610825-2012-00143
    Event Type
    Malfunction
    Date Received
    September 6, 2012
    Date of Event
    August 8, 2012
    Report Date
    September 6, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). IN A FOLLOW UP WITH THE REPORTING FACILITY, IT WAS INDICATED THAT THE NURSE NOTICED THE SAFETY CLIP DID NOT DEPLOY WHEN SHE WAS PUTTING THE USED NEEDLE BACK INTO THE PACKAGING. THE SAMPLE AND ALL AVAILABLE INFO WAS FORWARDED TO THE ACTUAL MANUFACTURER FOR FURTHER EVALUATION. ONE USED NEEDLE (CONTAMINATED WITH BLOOD) TOGETHER WITH THE PACKAGING LABEL 2C07258318/4051652-02, WAS RECEIVED FOR EVALUATION. THE CATHETER WAS NOT RETURNED WITH THE NEEDLE. THE RETURNED SAMPLE WAS VISUALLY CHECKED AND FOUND THAT THE SAFETY CLIP WAS LOCATED AT THE CANNULA HUB. THE SAFETY CLIP (LONG ARM) WAS DAMAGED. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. A BATCH REVIEW WAS CONDUCTED AND NO ABNORMALITIES IN THE MANUFACTURE OF THE PRODUCT WERE NOTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS: IV STARTED, NURSE NOTICED CLIP HAD NOT FULLY DEPLOYED, SET TO SIDE, NO INJURY. EVENT OCCURRED IN ENDOSCOPY SUITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 2C07258318

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other