BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIFIX SOFT TIP

    MDR report key: 5766598 · Received July 1, 2016

    Report

    Report Number
    9610825-2016-00429
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 6, 2016
    Report Date
    June 7, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K112515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). NO SAMPLE HAS BEEN RETURNED FOR INVESTIGATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT. IF THE SAMPLE AND/OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). DESCRIPTION: PERIFIX ONE 400 FILTERSET MATERIAL NO: 4514009C, BATCH NO..: 16A26A8701. CAUSE STUDY: AFTER CHECKING THE RESPECTIVE DOCUMENTATION OF THE PRODUCTION (SHIFT RECORD, RESULTS OF WORKER SELF-INSPECTION AND IN-PROCESS CONTROL, MACHINE DOCUMENTATION, CLEANING RECORD ETC.) NO DEVIATIONS COULD BE IDENTIFIED IN THE MENTIONED TIME PERIOD.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): 2 CM OF THE KT IN THE BACK OF THE PATIENT. THE PART OF CATHETER REMAINED IN THE BACK OF THE PATIENT, THE PATIENT WILL BE INFORMED BUT THERE WILL BE NO INTERVENTIONS TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420051 PERIFIX SOFT TIP EPIDURAL CATHETER DQR B. BRAUN MELSUNGEN AG N/A 16A26A8701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other