BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAFIX® PRIMELINE

    MDR report key: 17262281 · Received July 5, 2023

    Report

    Report Number
    9610825-2023-00305
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Report Date
    October 5, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. AT THE TIME THE COMPLAINT WAS INITIATED, B. BRAUN ATTEMPTED TO OBTAIN SAMPLES AND ADDITIONAL INFORMATION CONCERNING THE CASE.

    Additional Manufacturer Narrative · 0

    WE RECEIVED ON UNUSED INTRAFIX PRIMELINE LL,180CM IN OPEN PACKAGING. FURTHERMORE, WE RECEIVED TWO CUSTOMER PICTURES. LOOSE PARTICLES (PVC) INSIDE THE LINE WERE DETECTED. BASED ON THE PROCESS TECHNOLOGY, IT COMES FROM ACCUMULATION OF PVC ON THE EXTRUSION MANDREL DURING MANUFACTURING AND ADDS UP TO A POSSIBLE PARTICLE OVER TIME. NO FURTHER COMPLAINTS HAVE BEEN REGISTERED FOR THE DESCRIBED ISSUE. THE RESIDUAL RISK HAS BEEN ASSESSED ACCORDING TO THE RISK MANAGEMENT STANDARDS OF ISO 14971. CURRENTLY WE RECEIVED ONE CASE FROM THE MARKET. CONSIDERING THE CLEANING INTERVAL AND ASSUMING THAT A PARTICLE COULD FORM AND DISSOLVE EVERY 24 HOURS, THE MAXIMUM NUMBER OF PARTICLES IS ASSUMED TO BE 18 PCS / WEEK. CALCULATION BASIS IS THE PRODUCTION LAYOUT WITH UP TO 5 EXTRUDERS / WEEK (STANDARD DISTRIBUTION: MONDAY 2, TUESDAY 2, WEDNESDAY 5, THURSDAY 2, FRIDAY 2, SATURDAY 5) WITH A PRODUCTION QUANTITY OF APPROX. 4.17 MIO PCS / YEAR. WE THEREFORE ASSUME A MAXIMUM ERROR RATE OF 4.3 PPM. THIS IS ASSUMED TO BE THE ABSOLUTE WORST CASE AND IS REDUCED IN PRACTICE BY MEANS OF PROCESS OBSERVATIONS BY THE WORKER. NOTE: 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY (B)(4)ORGANIZATION IN GERMANY: "TUBE CONTAMINATION." ACCORDING TO THE CUSOMER: "MOVABLE, BLACK PARTICLES IN THE INFUSION LINE WERE NOTICED IN TIME BEFORE APPLICATION TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343721 INTRAFIX® PRIMELINE SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MELSUNGEN AG 23D20A8421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown