BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12081015 · Received June 28, 2021

    Report

    Report Number
    3006948883-2021-00713
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 16, 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

    (B)(6). INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231182. 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. DHR REVIEW: THE COMPLAINT GAUGE IS 22G,ASSEMBLY AT AUTO LINE 4 IN AUG. 2020,PACKAGING AT CFS PACKING MACHINE IN SEP. 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. IT IS NOT POSSIBLE TO CONFIRM THAT THE SLIDE CLAMP IS NOT TIGHT. CHECK THE SLIDE CLAMP OF THIS LOT, NO ABNORMAL FOUND ON INCOMING INSPECTION. 2 PCS RETAINED SAMPLES WERE TAKEN FOR THE SLIDE CLAMP SEALING TEST, ALL PASSED. DURING THE TEST, IT WAS FOUND THAT WHEN THE EXTENSION TUBING WAS NOT CENTERED IN THE SLIDE CLAMP, THE SLIDE CLAMP COULD NOT BE FULLY ACTED. NO SAME COMPLAINT WAS RECEIVED FROM THE COMPLAINT LOT. CONCLUSION(S): NO DEFECTIVE SAMPLE RETURNED, AND NO ABNORMAL FOUND ON PROCESS, IT WAS NOT CLEAR HOW THE NURSE WAS USING AT THAT TIME, SO THE ROOT CAUSE OF DIFFICULTY IN CLAMPING EXTENSION TUBING IS NOT CLEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 22GAX1.00IN PRN/EC SLM TUBING CLAMP WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE GENERAL PRACTICE DEPARTMENT OF OUR HOSPITAL DUE TO "RODENTICIDE POISONING". ON (B)(6) 2021, THE PATIENT WAS GIVEN INDWELLING INFUSION WITH A CLOSED INTRAVENOUS INDWELLING NEEDLE ACCORDING TO THE DOCTOR'S ADVICE. ON (B)(6) 2021, THE PATIENT WAS FOUND TO HAVE HEMATOCELE AT THE DISTAL END OF THE INDWELLING NEEDLE SWITCH IN HIS LEFT HAND WHEN THE DOCTOR WAS MAKING ROOM ROUNDS ON THE TUBE BED. AFTER RESEALING THE TUBE IMMEDIATELY, THE SWITCH WAS STILL HEMATOCELE. AFTER EXAMINATION, IT WAS FOUND THAT THE SWITCH COULD NOT BE CLAMPED FIRMLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976787 INTIMA-II Y 22GAX1.00IN PRN/EC SLM CATHETER FOZ BD (SUZHOU) 0231182

    Patients

    Seq Age Sex Outcome Treatment
    1