BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2980101 · Received February 20, 2013

    Report

    Report Number
    9610825-2013-00017
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    January 22, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). IN A F/U CALL TO THE FACILITY TO GAIN ADDITIONAL INFO, THE REPORTER STATED THAT THE EVENT OCCURRED ON (B)(6) 2013. THE NURSE WAS INJURED WHEN DISPOSING OF THE NEEDLE WHILE CLEANING UP. THE SAFETY CLIP DISLODGED FROM END OF THE NEEDLE WHILE PICKING UP THE NEEDLE AND THE USED SUPPLIES ALL TOGETHER. THE NURSE IS FOLLOWING PROTOCOL FOR THE NEEDLE STICK. THE PICTURE AND ALL AVAILABLE INFO WERE FORWARDED TO THE ACTUAL MFR, B. BRAUN (B)(4). THEY CONCLUDED THAT WITHOUT THE ACTUAL SAMPLE, IT IS DIFFICULT TO CONDUCT FURTHER INVESTIGATION AS A CONCLUSION CANNOT BE DRAWN BY OBSERVATION FROM A PICTURE. THE BATCH RECORD WAS NOT ABLE TO BE REVIEWED AS THE BATCH NUMBER WAS NOT KNOWN. A HISTORICAL REVIEW OF THE COMPLAINT DATABASE INDICATED THAT NO ADVERSE QUALITY TRENDS WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR ITEM #4251687-02. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IT SHOULD BE NOTED THAT THE INTROCAN SAFETY IS DESIGNED TO REDUCE THE RISK OF NEEDLE STICK INJURY. HOWEVER, CDC GUIDELINES AND/OR FACILITY PROTOCOL SHOULD ALWAYS BE FOLLOWED. SHARPS SHOULD BE DISPOSED OF IMMEDIATELY INTO AN APPROPRIATE SHARPS CONTAINER. IF ADDITIONAL PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REF # 4251687-02: REPORTS NEEDLE STICK INJURY OCCURRED WHEN CLEANING UP. AFTER IV INSERTION, SAFETY CLIP DISLODGING FROM END OF NEEDLE WHILE PICKING IT AND THE USED SUPPLIES ALL TOGETHER. REGULAR FACILITY PROTOCOL WAS FOLLOWED. CUSTOMER DISCARDED THE SAMPLE, BUT DID TAKE A PICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74191 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other