BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 17961170 · Received October 18, 2023

    Report

    Report Number
    9610825-2023-00485
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    July 5, 2023
    Report Date
    October 18, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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). 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. BMI COMPLAINT MANAGEMENT DATED (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 22K01G8316 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. NOTE: AWAITING FOR SAMPLE FROM BBAJ. SAMPLE RECEIPT AT BMI - COMPLAINT INVESTIGATOR, DATED 2023-10-03. BMI PRELIMINARY INVESTIGATION: - RECEIVED 1 USED AND CONTAMINATED CAPILLARY HUB OF INTROCAN SAFETY PUR 22G, 0.9X25MM; -JP WITHOUT PACKAGING. CANNULA HUB AND PROTECTIVE CAP WERE NOT BEING RETURNED FOR INVESTIGATION. BASED ON TEST SPEC #: HC-MY01-M-5-4-10-027-0, TOOK THE SAMPLE TO A VISUAL TEST ACCORDING TO TEST METHOD 102000 (VISUAL) / TEST METHOD 102002 (DAMAGES) AND NO ABNORMALITIES OR DAMAGES FOUND. SAMPLE WAS THEN TESTED USING A SYRINGE AND UPON INJECTING WITH SALINE, NO LEAKAGE WAS OBSERVED (PLEASE REFER TO PICTURES ATTACHED IN PC NOTIFICATION). NOTE: FORWARDED THE SAMPLE TO PRODUCTION FOR FURTHER EVALUATION AND INVESTIGATION. ROOT CAUSE ANALYSIS: MACHINE PRODUCTION COMPLETION DATE. PACKING S/PACKET : 12111195. PACKING MACHINE F57, 2022-09-01. ETO CHANNEL STERIS, 2022-09-15. FINAL SHOP PACKET NO: 12111199; BATCH: 22H27G0056 & 22H28G0045; ARTICLE NO : 4251628UP1. CAM, D376, 2022-08-28; CAL , D377, 2022-08-28; ECM, D375 , 2022-08-28. PROCESS CARDS SHOW NO ABNORMALITIES. TREND ANALYSIS. CUSTOMER COMPLAINT OF LOCK CONNECTOR / TIGHTNESS - GENERAL FOR INTROCAN SAFETY TREND ANALYSIS IS BEING TRACKED BASED ON CAPA INITIATION CRITERIA. SAMPLE RECEIVED, (REFER TO CIR): RECEIVED 1PCS USED AND CONTAMINATED CATHETER HUB ONLY OF INTROCAN SAFETY PUR 22G, 0.9X25MM-JP WITHOUT PACKAGING. CANNULA HUB AND PROTECTIVE CAP WERE NOT BEING RETURNED FOR INVESTIGATION. NO JMS CONNECTOR RETURNED FOR INVESTIGATION. SAMPLE INVESTIGATION · THE RETURNED CATHETER HUB WAS INVESTIGATED FOR ANALYSIS, REFER INSPECTION TABLE BELOW. (REFER TO CIR): SIMULATION 1. CONNECTION OF CATHETER HUB TO THE B. BRAUN INFUSOMAT EXTENSION LINE. · SIMULATION WAS PERFORMED ON THE RETURNED CATHETER HUB SAMPLE WITH B. BRAUN INFUSOMAT EXTENSION LINE TO CHECK FOR LEAKAGE. · RESULT: THERE WAS NO LEAKAGE OBSERVED AT THE CATHETER HUB LUER CONNECTION AREA. (REFER TO CIR): SIMULATION 2. CONNECTION OF CATHETER HUB TO SYRINGE. · SIMULATION WAS PERFORMED ON THE RETURNED CATHETER HUB SAMPLE WITH 10ML SYRINGE TO CHECK FOR LEAKAGE. · RESULT: THERE WAS NO LEAKAGE OBSERVED AT THE CATHETER HUB LUER CONNECTION AREA. (REFER TO CIR): REVIEW OF PROCESS CARD. · THE COMPLAINT BATCH WAS PRODUCED AT BRAUN 3 INTROCAN LINE 4. (REFER TO CIR): · PROCESS CARDS FOR B3 INTROCAN LINE 4 WERE REVIEWED. NO ABNORMALITY OBSERVED. REVIEW OF ASSEMBLY PROCESS FLOW. INTROCAN CATHETER ASSEMBLY LINE (CAL). (REFER TO CIR): AT CAL MACHINE, THE CATHETER LEAKAGE TEST STATION CAN DETECT SAMPLES THAT OBSERVED WITH CUT/DAMAGE CAPILLARY, INCOMPLETE ASSEMBLY OF CAPILLARY ATTACHED TO CATHETER HUB AND DAMAGE/CRACK CATHETER HUB. WHEN SUBJECTING TO THIS LEAKAGE TEST, A SAMPLE THAT EXCEEDS THE LEAKAGE PRESSURE SPECIFICATION INDICATES LEAKAGE WAS FOUND AND IT WOULD BE AUTOMATICALLY REJECTED AND REMOVED AT THE EJECT REJECT PART STATION. THE IN-LINE TEST EQUIPMENT IS SUBJECT OF A FREQUENT CALIBRATION AND A REGULAR VERIFICATION RELATED TO ITS PROPER FUNCTION. HEREWITH POTENTIAL MALFUNCTIONS OF THE SYSTEMS WOULD BE DETECTED IN-TIME AND WOULD BE MITIGATED. BESIDE THE AUTOMATED 100% IN-LINE TEST EQUIPMENT, INDEPENDENT IN-PROCESS QUALITY CONTROLS AND FINAL CONTROLS ON A RANDOM SAMPLE BASIS WILL BE CONDUCTED BY DIFFERENT TEAMS ON A REGULAR BASIS WITHIN THE PRODUCTION PROCESS. HEREWITH A SYSTEMATIC PRODUCT DEFECT WOULD BE DETECTED. REVIEW OF FINAL CONTROL INSPECTION RESULTS TEST SPECIFICATION: INTROCAN STERILE (DOC. NO.: HC-MY01-M-5-4-10-027-0). (REFER TO CIR): · FINAL CONTROL VISUAL INSPECTION AND FUNCTIONAL TEST RESULTS FOR 22K01G8316 WERE REVIEWED. · ALL RESULTS WERE REPORTED AS PASSED. REVIEW OF IPQC INSPECTION RESULTS · IPQC SHORT SHOT (INCOMPLETE MOULDING), MATERIAL PROJECTIONS, DAMAGES, AIR TIGHTNESS 300 KPA/30 S ((B)(4)) OF VEIN CATHETER (CAPILLARY), BETWEEN CATHETER (CAPILLARY) AND CATHETER HUB (INCL. INNER TAPER OF HUB) AND HIGH PRESSURE TEST 300 PSI ((B)(4)) FOR 10 S TEST RESULTS FOR ASSEMBLY SHOP PACKET 12111199 WERE REVIEWED. THE RESULTS WERE REPORTED AS PASSED. · IPQC AND FINAL CONTROL HOLDBACK RECORD WAS REVIEWED. NO DAMAGE OR FUNCTIONAL RELATED HOLDBACK REPORTED FOR COMPLAINT BATCH 22K01G8316. SUMMARY OF ROOT CAUSE ANALYSIS: · RECEIVED 1PCS USED AND CONTAMINATED CATHETER HUB ONLY OF INTROCAN SAFETY PUR 22G, 0.9X25MM-JP WITHOUT PACKAGING. CANNULA HUB AND PROTECTIVE CAP WERE NOT BEING RETURNED FOR INVESTIGATION. NO JMS CONNECTOR RETURNED FOR INVESTIGATION. · THE RETURNED SAMPLE WAS INSPECTED AT BMI AND PASSED THE TESTS. · PROCESS CARD WAS REVIEWED. NO ABNORMALITY DURING MANUFACTURING OF THE COMPLAINT BATCH 22K01G8316. · PROCESS FLOW WAS REVIEWED. WHEN SUBJECTING TO THIS CATHETER LEAKAGE TEST STATION, A SAMPLE THAT EXCEEDS THE LEAKAGE PRESSURE SPECIFICATION INDICATES LEAKAGE WAS FOUND AND IT WOULD BE AUTOMATICALLY REJECTED AND REMOVED AT THE REJECT PART STATION. · FINAL CONTROL AND IPQC VISUAL INSPECTION AND FUNCTIONAL TEST RESULTS WAS REVIEWED FOR BATCH 22K01G8316. ALL RESULTS WERE REPORTED AS PASSED. · THIS COMPLAINT IS CONCLUDED AS NOT CONFIRMED. CAUSE: CAUSE COULD NOT BE DETERMINE. THE RETURNED SAMPLE HAS BEEN CHECKED AND TESTED BYBMI. THE SAMPLE PASSED THE TESTS CONDUCTED AND THEY MEET THE SPECIFICATIONS. REVIEW OF PROCESS CARD AND FINAL CONTROL RECORD SHOWED NO DEVIATION DURING MANUFACTURING PROCESS AND FINAL CONTROL INSPECTION. THEREFORE, THIS COMPLAINT IS CONCLUDED AS 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 JAPAN: "PRODUCT LEAKAGE" ACCORDING TO THE CUSTOMER: "IT WAS USED IN COMBINATION THERAPY WITH PEMBROLIZUMAB (GENETICAL RECOMBINATION), EPIRUBICIN HYDROCHLORIDE AND CYCLOPHOSPHAMIDE HYDRATE. WHEN CONNECTED TO ANOTHER COMPANY'S PRODUCT AND ADMINISTERING EPIRUBICIN HYDROCHLORIDE, LEAKED. THERE WERE NO DETACHED OR LOOSE CONNECTIONS. AFTER RETIGHTENING AND RESTARTING ADMINISTRATION, IT LEAKED AGAIN DURING SALINE WASHOUT. THERE WERE NO CRACKS IN THE PRODUCT. THIS HAS HAPPENED THREE TIMES IN TOTAL, THIS TIME AND THE LAST TWO TIMES. INVESTIGATED BY THE MANUFACTURER OF THE CONNECTED PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617989 INTROCAN SAFETY® I.V. SAFETY CATHETER FOZ B BRAUN MELSUNGEN AG 4251628JP 22K01G8316

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown