BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 8596668 · Received May 9, 2019

    Report

    Report Number
    9610825-2019-00140
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    March 28, 2019
    Report Date
    January 9, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS EVENT TWO OF B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). WE RECEIVED: ONE USED PERIFIX CATH.CON. 2.0 G20-G24 YELLOW OUT OF A PERIFIX-SOFT-TIP 701 SET 18G FILTER LOR WITHOUT PACKAGING. THE SAMPLE IS CLOSED AND CONNECTED WITH A PERIFIX FILTER. THE DEFECT IS DUE TO A DEVELOPMENT ERROR AND ALREADY KNOWN. THEREFORE THIS COMPLAINT IS CONSIDERED AS CONFIRMED. THE COMPLAINT IS FILED FOR STATISTICAL PURPOSE. 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. THE PRODUCT DESIGN IS BEING UPDATED TO INCREASE THE FORCE REQUIRED TO OPEN THE CATHETER CONNECTOR UNDER CHANGE CONTROL: HC-CHC-M-DIV-1306. NOTES: 1. THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. 2. B. BRAUN IS AWARE THAT THE LISTED EXEMPTION HAS BEEN WITHDRAWN, HOWEVER SINCE THE INITIAL MDR REPORT WAS FILED UNDER THIS EXEMPTION, THE FOLLOW UP IS ALSO BEING FILED UNDER THE EXEMPTION.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS EVENT TWO OF B. BRAUN MELSUNGEN AG INTERNAL REPORT #(B)(4). THIS REPORT HAS BEEN IDENTIFIED AS EVENT TWO OF B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). NO SAMPLE HAS BEEN RETURNED FOR INVESTIGATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH INVESTIGATION CAN NOT BE PERFORMED. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER. A FOLLOW UP REPORT WILL BE FILED WHEN THE RESULT OF THE BATCH REVIEW IS DONE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN ITALY): EVENT 2 OPENING OF THE CATHETER: SPONTANEOUS OPENING OF THE CATHETER AND CONSEQUENT EXTRACTION OF THE CATHETER ITSELF WITH CONSEQUENT LOSS OF STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389058 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MELSUNGEN AG 18H01A8701

    Patients

    Seq Age Sex Outcome Treatment
    1