BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFELINE INJECTION SITE

    MDR report key: 3222066 · Received July 5, 2013

    Report

    Report Number
    9614279-2013-00013
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Report Date
    June 11, 2013
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K931377
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER A THOROUGH EVAL COULD NOT BE PERFORMED. HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE REPORTING FACILITY, IT WAS STATED THAT THE PRODUCT WAS BEING USED WITH NEEDLES IN PLACE OF THE SAFELINE CANNULA. PER THE INSTRUCTIONS FOR USE (IFU), THE SAFELINE INJECTION SITE IS INTENDED TO BE USED WITH THE B. BRAUN SAFELINE SYSTEM. THE SEPTUM OF THE SAFELINE INJECTION SITE CONTAINS A PRE-PIERCED SLIT AND IS DESIGNED TO BE USED WITH A SAFELINE CANNULA. THE SAFELINE CANNULA IS TO BE INSERTED TO THE APPROPRIATE DEVICE THROUGH THE CENTER OF THE SEPTUM. THIS DEVICE IS NOT INTENDED TO BE USED WITH A NEEDLE. MEDICATION ADDITIONS REQUIRING A CONVENTIONAL NEEDLE SHOULD BE USED IN EMERGENCY SITUATIONS ONLY. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE PRODUCT CATALOG NUMBER IDENTIFIED IN THE REPORTED EVENT. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THAT NUCLEAR MEDICINE DEPT REPORTS THAT PRODUCT IS LEAKING, BUT NOTHING SPECIFIC. DURING A FOLLOW-UP CALL TO (B)(6) FROM THE NUCLEAR MEDICINE DEPT AT THE REPORTING FACILITY, SHE CONFIRMED THERE WAS NO INJURY OR INTERVENTION NEEDED TO THE PT OR STAFF AS A RESULT OF THIS INCIDENT. STATED NEEDLES WERE BEING USED IN PLACE OF THE SAFELINE CANNULA BECAUSE THE AMOUNT OF MEDICINE USED IN THE PROCEDURES WAS VERY MINIMAL. SHE ALSO STATED A DIFFERENCE WAS NOTED IN THE NEW STYLE OF SEPTUMS AND THAT LEAKING STARTED WHEN USING THE NEW STYLE. NO SAMPLE WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307616 SAFELINE INJECTION SITE NEEDLELESS SPLIT SEPTUM INJECTION SITE FPA B. BRAUN DOMINICAN REPUBLIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other