BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFELINE INJECTION SITE

    MDR report key: 3184734 · Received June 12, 2013

    Report

    Report Number
    9614279-2013-00010
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Report Date
    May 21, 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
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. 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: CUSTOMER REPORTED THAT PRODUCT IS LEAKING WHEN RADIOACTIVE ISOTOPES ARE INJECTED INTO THE PRODUCT USING A NEEDLE. CUSTOMER REPORTS PRIOR TO PRODUCT CHANGE, THEY NEVER HAD THIS ISSUE. DURING A FOLLOW-UP CALL TO THE FACILITY, THE REPORTER CONFIRMED THAT THE SAMPLE WAS NOT SAVED AND IS NOT AVAILABLE TO BE RETURNED. THE REPORTER INDICATED THAT THE LEAKAGE WAS MINIMAL AND THAT THERE WAS NO INJURY OR INTERVENTION REQUIRED TO THE PATIENT OR STAFF AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267277 SAFELINE INJECTION SITE NEEDLELESS SPLIT SEPTUM INJECTION SITE FPA B. BRAUN DOMINICAN REPUBLIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other