BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN®-W

    MDR report key: 18282607 · Received December 7, 2023

    Report

    Report Number
    9610825-2023-00563
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    August 10, 2023
    Report Date
    December 6, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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. PROBLEM ANALYSIS LIMITED DEFECT MODE DESCRIBED IN THE COMPLAINT DESCRIPTION WHICH STATED, "CT WAS PERFORMED TO DETERMINE WHETHER THE INDWELLING NEEDLE CATHETER REMAINED IN THE BLOOD VESSEL". HOWEVER, THERE WAS NO FURTHER INFORMATION ON METHOD OF HANDLING OF PRODUCT. NO SAMPLE OR PICTURE OF THE DEFECT MODE PROVIDED FOR FURTHER EVALUATION. SIMULATION THE VENIPUNCTURE WAS SIMULATED AND BLOOD IS VISIBLE IN THE CANNULA HUB CHAMBER PICTURE 1. THEN, THE CATHETER WAS ADVANCED OFF THE NEEDLE PICTURE 2, AND ASSUMING THAT NO BLOOD VISIBLE IN THE CATHETER (NO SECOND FLASHBACK). TRY TO REINSERT THE CANNULA BACK INTO THE VEIN WHICH POSSIBLY COULD RESULTING IN CUT OF THE CATHETER AS IN PICTURE 3. (REFER TO CIR) AS COMMUNICATED IN IFU: THE WARNING SECTION STATED: AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM. PROCESS ANALYSIS: THE PROCESS MAPPING FOR CATHETER ASSEMBLY LINE (CAL) AND END CONTROL MACHINE (ECM) FOR INTROCAN HAS BEEN REVIEWED AND SUCH DEFECT SHALL BE DETECTED DURING CATHETER PRESENT CHECK STATION, CATHETER TIP INSPECTION STATION AND TRIM LENGTH, BEVEL & CONTOUR VISION INSPECTION STATION. TEAR-OFF/BROKEN CAPILLARY WILL RESULT IN LOST DETECTION OF THE CATHETER TIP. THIS WILL BE AUTOMATICALLY REJECTED BY THE INLINE VISION CAMERA BY BOTH PROCESSES CAL AND ECM. CAL PROCESS FLOW (REFER TO CIR). ECM PROCESS FLOW (REFER TO CIR). ALL THE IN-LINE TEST EQUIPMENT IS SUBJECT TO FREQUENT CALIBRATION AND REGULAR VERIFICATION RELATED TO ITS PROPER FUNCTION. HEREWITH POTENTIAL MALFUNCTIONS OF THE SYSTEMS WOULD BE DETECTED IN TIME AND WOULD BE MITIGATED IMMEDIATELY. IN-PROCESS QUALITY CONTROLS AND FINAL CONTROLS ON A RANDOM SAMPLE, THE BASIS WAS CONDUCTED BY DIFFERENT TEAMS ALONG THE PRODUCTION PROCESS. HEREWITH ANY SYSTEMATIC PRODUCT DEFECT WOULD BE DETECTED. SIMULATION 1: (REFER TO CIR). THE CATHETER OF THE SIMULATION SAMPLE WAS PURPOSELY CUT OFF TO 14.02MM (PICTURE 1). WHEN THE SIMULATION SAMPLE GO THROUGH THE VISION SYSTEM, IT WAS REJECTED BECAUSE IT COULD NOT DETECT THE CATHETER TIP AS THE LENGTH WAS TOO SHORT. THEREFORE, IT WILL BE AUTOMATICALLY REJECTED. SIMULATION 2: (REFER TO CIR). WHEN THE SIMULATED DEFECTIVE SAMPLE (14.02 MM) GOES THROUGH ECM TRIM LENGTH CHECK, THE SYSTEM WILL REJECT THE SAMPLE AS IT DID NOT MEET THE CRITERIA OF THE ACCEPTABLE MEASUREMENT. THE IN-LINE TEST EQUIPMENT IS SUBJECT OF FREQUENT CALIBRATION AND REGULAR VERIFICATION RELATED TO ITS PROPER FUNCTION. HEREWITH POTENTIAL MALFUNCTIONS OF THE SYSTEMS WOULD BE DETECTED IN TIME AND WOULD BE MITIGATED ASAP. MANUFACTURING CONTROL. ALL THE PRODUCTS ARE SUBJECTED TO IN-PROCESS QUALITY CONTROLS AND FINAL CONTROLS INSPECTION ON A RANDOM SAMPLE BASIS WHICH HAS BEEN CONDUCTED BY DIFFERENT TEAMS ON A REGULAR BASIS WITHIN THE PRODUCTION PROCESS TO ENSURE THE PRODUCT ARE FREE FROM ANY DAMAGES. HEREWITH A SYSTEMATIC PRODUCT DEFECT WOULD BE DETECTED. BATCH ANALYSIS. FINAL CONTROL TEST RESULT: (REFER TO CIR) THIS IS TO CHECK VISIBLE CHANGES IN THE ORIGINAL SHAPE OR SURFACE OF PRODUCTS CAUSED BY MECHANICAL FORCES AND/ OR MANUFACTURING FAULTS. THERE SHALL BE NO DAMAGE TO THE OVERALL PRODUCT CONDITION. SPECIFICATION FOR CAPILLARY SURFACE: NO DAMAGES SUCH AS SPLIT, KINKS, BUMPS, OR SCRATCHES ARE ACCEPTED. THE COMPLAINT BATCH PASSED ALL THE ABOVE TESTS AND SHOWED NO ABNORMALITIES. SUMMARY OF ROOT CAUSE ANALYSIS: AS THE AFFECTED SAMPLE AND PHOTO WAS NOT PROVIDED, FURTHER EVALUATION IS NOT POSSIBLE. HENCE THE ROOT CAUSE COULD NOT BE DETERMINED. CAUSE : CAUSE COULD NOT BE DETERMINE ALL THE PRODUCTS WERE MANUFACTURED MOST LIKELY NOT TO BE ATTRIBUTED BY THE MANUFACTURING PROCESS AS THE DEFECTIVE SAMPLE IS ABLE TO BE DETECTED AND REJECTED BY THE IN-LINE TESTER OF THE EQUIPMENT. ALL THE INTROCAN SAFETY PRODUCTS WERE MANUFACTURED IN ACCORDANCE WITH THE PRODUCT SPECIFICATION OF - INTROCAN® (RMF-120-001-PS-01). WITHOUT THE ACTUAL SAMPLE AND PICTURE, FURTHER EVALUATION WAS NOT POSSIBLE, AND THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THEREFORE, THIS COMPLAINT IS CONCLUDED NOT CONFIRMED. CORRECTIONS/CONTAINMENT PLANS WITH EFFECTIVE DATE: NOT APPLICABLE. CORRECTIVE ACTIONS WITH EFFECTIVE DATE: NOT APPLICABLE. JUSTIFICATION: NOT CONFIRMED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN CHINA: "NEEDLE HANDLE-BROKEN OFF" ACCORDING TO THE CUSTOMER: "DESCRIPTION OF MALFUNCTION/FAILURE:I.V. CANNULA SAFETY DESIGNED TO MINIMIZE INADVERTENT NEEDLE STICKS, WITH AND WITHOUT FIXATION WING CATHETER NEEDLE HANDLE DISCONNECTED DESCRIPTION OF EVENT:I.V. CANNULA SAFETY DESIGNED TO MINIMIZE INADVERTENT NEEDLE STICKS, WITH AND WITHOUT FIXATION WING CATHETER NEEDLE HANDLE DISCONNECTED PRELIMINARY HANDLING OF EVENT:CT WAS PERFORMED TO DETERMINE WHETHER THE INDWELLING NEEDLE CATHETER REMAINED IN THE BLOOD VESSEL NI FUTHER INFORMATION"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128631 INTROCAN®-W CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 4254074B 22N07G8391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown