BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 8605355 · Received May 13, 2019

    Report

    Report Number
    9610825-2019-00177
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 3, 2019
    Report Date
    May 13, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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 B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). WE RECEIVED 1 SET OF CONNECTOR AND FILTER CONNECTED TO A PUMP MADE BY OTHER MANUFACTURER AND A SEPARATE CATHETER. THE COVER OF RECEIVED CONNECTOR WAS LOCKED. VISUAL INSPECTION. ON THE CATHETER, DAMAGES AT LOCATIONS OF 711MM AND 820MM FROM THE END WERE OBSERVED. NO OTHER ABNORMALITY WAS OBSERVED ON CATHETER. CONNECTOR DID NOT SHOW ANY ABNORMALITY THAT MAY BE LINKED TO FALLING OUT. DIMENSION CHECK OF CATHETER TOTAL LENGTH: 1033MM, SATISFIES STANDARD OF 990-1070MM. OUTER DIAMETER AT END: 0.8490MM, SATISFIES STANDARD OF 0.84-0.90MM. FUNCTIONAL TEST. CATHETER TENSILE STRENGTH TEST: RETURNED CATHETER WAS CONNECTED WITH RETURNED CONNECTOR AND DETERMINED THE STRENGTH. RESULT: 14.4 N (SPEC>11N). THE TENSILE STRENGTH OF CATHETER + CATHETER CONNECTOR WERE MET SPECIFICATION. OTHER TESTS. WHEN THE RETURNED CATHETER WAS CONNECTED TO THE RETURNED CONNECTOR, CATHETER WAS ABLE TO BE INSERTED WITHOUT RESISTANCE. END OF CATHETER WAS ABLE TO BE INSERTED UP TO STANDARD INSERTION POSITION INTO CATHETER CONNECTOR AND COULD LOCK TIGHTLY. JUSTIFICATION. THIS COMPLAINT IS NOT CONFIRMED. NOTES: THIS CASE IS BEING FILED RETROSPECTIVELY AS A RESULT OF A REVIEW OF RECENT CUSTOMER COMPLAINT INFORMATION. BASED ON ADDITIONAL INFORMATION AND DETAILS PROVIDED IN ANOTHER COMPLAINT CASE, IT WAS DETERMINED THAT THIS CASE IS REPORTABLE IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. 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. THE PRODUCT DESIGN IS BEING UPDATED TO INCREASE THE FORCE REQUIRED TO OPEN THE CATHETER CONNECTOR UNDER CHANGE CONTROL: (B)(4).

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN: CATHETER DETACHED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398243 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1