BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX

    MDR report key: 10183620 · Received June 23, 2020

    Report

    Report Number
    9610825-2020-00121
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    March 14, 2020
    Report Date
    July 27, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). A REVIEW OF THE BATCH AND MANUFACTURING RECORDS REVEALED NO ABNORMALITIES OR NONCONFORMITIES. WE RECEIVED: NO SAMPLE, 4 PICTURES OF A USED PERIFIX CATHETER 0.45X0.85, 20G S-O IN OPEN PACKAGING. THE PERIFIX CATHETER ON THE PICTURE IS SHORN OFF. THE SHORN OFF AREA IS SLANTED AND SHOWS A SMOOTH STRUCTURE. SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF. PLEASE SEE INSTRUCTIONS FOR USE: "NEVER PULL THE CATHETER THROUGH THE NEEDLE AS IT MAY OTHERWISE SHEAR OFF." WE EXCLUDE A MANUFACTURING FAULT SINCE THE CATHETERS WERE TAKEN TO A 100% EXAMINATION AND THEREFORE NO MECHANICAL DAMAGES OR MANUFACTURING FAULTS ARE ALLOWED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). WE RECEIVED: NO SAMPLE, 4 PICTURES OF A USED PERIFIX CATHETER 0.45X0.85, 20G S-O IN OPEN PACKAGING. THE PERIFIX CATHETER ON THE PICTURE IS SHORN OFF. THE SHORN OFF AREA IS SLANTED AND SHOWS A SMOOTH STRUCTURE. SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF. PLEASE SEE INSTRUCTIONS FOR USE: "NEVER PULL THE CATHETER THROUGH THE NEEDLE AS IT MAY OTHERWISE SHEAR OFF." WE EXCLUDE A MANUFACTURING FAULT SINCE THE CATHETERS WERE TAKEN TO A 100% EXAMINATION AND THEREFORE NO MECHANICAL DAMAGES OR MANUFACTURING FAULTS ARE ALLOWED. THE COMPLAINT IS NOT CONFIRMED. 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 SOLD IN THE UNITED SATES BY B. BRAUN MEDICAL, INC. IF THE SAMPLE AND OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): CATHETER BROKE WHEN REMOVING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650684 PERIFIX CATHETER, CONDUCTION, ANESTHETIC BSO B. BRAUN MELSUNGEN AG 19L21A8701

    Patients

    Seq Age Sex Outcome Treatment
    1