BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 12170805 · Received July 14, 2021

    Report

    Report Number
    3006948883-2021-00797
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    May 29, 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

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231208. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. DHR REVIEW: THE COMPLAINT GAUGE IS 22G, ASSEMBLY AT AUTO LINE 4 IN (B)(6) 2020, LOT QUANTITY IS 136K. REVIEW THE IN PROCESS TEST AND OUTGOING TEST REPORT FOR THIS LOT PRODUCT, ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS, NO ABNORMAL FOR IT. REVIEW THE PRODUCTION RECORD AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCT, NO ABNORMALITY, DEVIATION OR REWORK ACTIVITIES. NO ACTUAL SAMPLE AND PICTURE RETURNED, THE EXACT LOCATION AND STATUS OF CATHETER BROKEN COULD NOT BE CONFIRMED, FURTHER ANALYSIS COULD NOT BE DONE. CHECK INCOMING INSPECTION RECORDS OF CATHETER, NO ABNORMALITY WAS OBSERVED. (THE CATHETER FOR PRODUCTION OF THIS BATCH IS PANEL MATERIAL, MATERIAL NUMBER: B5190AAL, BATCH NUMBER: 9326324/9326326). LEAKAGE TEST THE 2 RETAINED SAMPLES, ALL PASSED. NO SAME COMPLAINT WAS RECEIVED FROM THE COMPLAINT LOT. CONCLUSION(S): NO ABNORMAL FOUND ON PROCESS. AS NO DEFECTIVE SAMPLE RETURNED, FURTHER ANALYSIS COULD NOT BE DONE, THE ROOT CAUSE OF THE CATHETER BROKEN COULD NOT BE CONFIRMED. THE PLANT WILL CONTINUE TO MONITOR THE DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 22GAX1.00IN PRN/EC SLM WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT 13:00 ON (B)(6) 2021, THE NURSE USED THE INDWELLING NEEDLE FOR THE NINE BEDS OF (B)(6). WHEN ROTATING THE NEEDLE CAP AND VENTING THE AIR, IT WAS FOUND THAT THE INDWELLING NEEDLE HOSE WAS BROKEN AND REPLACED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061533 INTIMA-II Y 22GAX1.00IN PRN/EC SLM CATHETER FOZ BD (SUZHOU) 0231208

    Patients

    Seq Age Sex Outcome Treatment
    1