BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX SOFT TIP

    MDR report key: 7805321 · Received August 22, 2018

    Report

    Report Number
    9610825-2018-00171
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Report Date
    December 5, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K112515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER THIS ITEM OR SIMILAR ITEMS ARE USED IN PRODUCTS THAT ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. WE RECEIVED: ONE OPTICAL UNUSED PERIFIX CATHETER AND ONE USED PERIFIX CATHETER CONNECTED WITH A PERIFIX CATHETER CONNECTOR AND A PERIFIX FILTER OUT OF A PERIFIX ONE 401 FILTERSET WITHOUT PACKAGING. THE SAMPLES ARE CONNECTED WITH AN EXTENSION LINE. THE PROVIDED PERIFIX CATHETERS WERE SUBJECTED TO A VISUAL EXAMINATION. AS-RECEIVED CONDITION THE USED CATHETER IS CUT OFF, AT THE SECOND CATHETER WE DETECTED NO DAMAGES. AFTERWARDS THE LENGTH OF THE CUT OFF PERIFIX CATHETER WAS MEASURED ACCORDING TO DRAWING. NOMINAL: 1010 +/- 7.5 MM ACTUAL: 990 MM THE SHORN OFF PART INCLUDING THE CATHETER TIP WAS NOT HANDED OVER. SUCH DAMAGES MAY OCCUR WHEN THE CATHETER HAS BEEN WITHDRAWN AGAINST THE CANNULA BEVEL AND SHEARING THE CATHETER TIP. INSTRUCTIONS FOR USE: "NEVER PULL THE CATHETER THROUGH THE NEEDLE AS IT MAY OTHERWISE SHEAR OFF." THE CATHETERS ARE SUBJECTED TO A 100 % EXAMINATION DURING MANUFACTURE, THEREFORE, MECHANICAL DAMAGE AND MANUFACTURING FAULTS CAN BE EXCLUDED. WE ASSUME A PROBLEM DURING APPLICATION. THIS COMPLAINT IS NOT CONFIRMED. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY AND REQUESTED A BATCH REVIEW. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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). 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 TAIWAN: CATHETER WAS BROKEN OFF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646292 PERIFIX SOFT TIP EPIDURAL CATHETER DQR B. BRAUN MELSUNGEN AG N/A 18B12A8701

    Patients

    Seq Age Sex Outcome Treatment
    1