BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 12178533 · Received July 15, 2021

    Report

    Report Number
    3006948883-2021-00799
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 16, 2021
    Report Date
    June 29, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 1032123. MEDICAL DEVICE EXPIRATION DATE: 2024-02-03. DEVICE MANUFACTURE DATE: 2021-02-01. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1032123. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, A SAMPLE WAS SUBMITTED BY THE FACILITY TO AID IN EVALUATION AND INVESTIGATION. OUR TEAM OF QUALITY ENGINEERS WERE ABLE TO OBSERVE A SMALL CRACK DURING LEAKAGE TESTING, THIS CRACK WAS LOCATED ON THE BODY OF THE ADAPTER. AFTER BISECTING THE DEVICE A CLOSER INSPECTION OF THIS UNITS SWAGING DEPTH WERE FOUND TO BE OUTSIDE OF THE ACCEPTABLE LIMITS. THIS IS MOST LIKELY THE RESULT OF VARIANCE IN THE SWAGING PROCESS. TO PREVENT A FUTURE OCCURRENCES OUR FACILITY HAS OPTIMIZED THE MANUFACTURING PROCESS TO NARROW THE ACCEPTABLE RANGE OF SWAGING DEPTHS. INVESTIGATION CONCLUSION: THE COMPLAINT GAUGE IS 24G,ASSEMBLY AT AUTO LINE 2 IN FEB. 2021, LOT QUANTITY IS 93K. REVIEW THE IN PROCESS TEST AND OUTGOING TEST REPORT FOR THIS LOT PRODUCT, ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS, NO ABNORMALITY FOR IT. REVIEW THE PRODUCTION RECORD AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCT, NO ABNORMALITY, DEVIATION OR REWORK ACTIVITIES. SAMPLE ANALYSIS: VIDEO AND A DEFECT SAMPLE RETURNED, LEAKAGE FROM THE CATHETER ADAPTER , THE GAUGE WAS 24G, P/N WAS 383028,LOT NUMBER WAS 1032123. THE DEFECT SAMPLE WAS EXAMINED UNDER A MICROSCOPE, AND IT WAS FOUND THAT THE CATHETER ADAPTER OUTSIDE THE METAL WEDGE WAS CRACKED. THE CATHETER ADAPTER MOLD NUMBER OF THIS SAMPLE WAS S17,THE DIE DEPTH WAS 18.173MM, WHICH WAS UNQUALIFIED. IN MANUFACTURE, DUE TO OCCASIONAL FLUCTUATION OF EQUIPMENT DURING OPERATION, THE CATHETER ADAPTER MAY CAUSE CRACKING, THE CATHETER ADAPTER CRACK MAINLY FOCUSED ON ADAPTER SWAGING PROCESS. ACTUALLY THERE IS AN INTERNAL IMPROVEMENT PROJECT FOR THIS DEFECT. 1) IT WAS TO OPTIMIZE CATHETER ADAPTER MOLDING CAVITY. 2) NARROW THE CONTROL LIMIT RANGE FOR SWAGING DEPTH. 3) ACCORDING TO THE INSPECTION OD DATA OF METAL WEDGE AND CRACKING DATA OF MOLD CAVITY, CHOOSE MATCHING MATERIAL FOR METAL WEDGE WITH CATHETER ADAPTOR CAVITY NUMBER. LEAKAGE TEST THE 2 RETAINED SAMPLES, ALL PASSED. AT THE SAME TIME, THE CATHETER ADAPTER OF THE RETAINED SAMPLE WAS CHECKED, AND NO ABNORMALITY WAS FOUND. NO SAME COMPLAINT WAS RECEIVED FROM THIS COMPLAINT LOT. THE LEAKAGE OF THE INDWELLING NEEDLE WAS DUE TO A CRACK IN THE CATHETER ADAPTER, THE CRACK MAY BE CAUSED BY THE ABNORMAL DEPTH OF THE SWAGING. THERE HAVE BEEN SOME IMPROVEMENT MEASURES IN PRODUCTION, THE DEFECT IS INDIVIDUAL CASE. THE PLANT CONTINUES PAY ATTENTION THIS TYPE OF COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE MORNING OF (B)(6) 2021, NURSE IN HOSPITAL WAS PREPARATION FOR INFUSION TO THE PATIENT, OPEN RACE 24 G M STRAIGHT TYPE PACKAGING, CONNECTION INFUSION DEVICE, PIERCING BEFORE, CHECK THE INDWELLING NEEDLE, FOUND CATHETER DRAINAGE CONDITION, IMMEDIATELY REPLACE OTHER IV FLUIDS, NO IMPACT ON PATIENTS, RECOVERY EVENT RELATED SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073522 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1