BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10977007 · Received December 9, 2020

    Report

    Report Number
    3006948883-2020-00925
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    October 27, 2020
    Report Date
    December 22, 2020
    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 · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140313 . 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A LOOSE TUBING CLAMP AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT CAME TO THE HOSPITAL FOR DUE TO HEART FAILURE. DURING THE USE OF BD LIEN NEEDLE, THE CLIP WAS NOT CLOSED COMPLETELY AND THE PATIENT'S BLOOD RETURNED, CAUSING MISUNDERSTANDING AMONG FAMILY MEMBERS AND INCREASING THE RISK OF INFECTION. SO IT WAS CHANGED ANOTHER INDWELLING NEEDLE TO PUNCTURE AFTER EXTUBATION. ************************************************************* 2020-11-17 RECEIVED AN UPDATE FROM THE SALES REPRESENTATIVE. THE EVENT DESCRIPTION IS UPDATED AS FOLLOWS: FEEDBACK INFORMATION ABOUT THE COMPLAINT IS AS FOLLOWS: MODEL GY IS 22, 383019, BATCH NUMBER, 0140313, AT THAT TIME, THE SITUATION DID NOT TAKE PHOTOS AND THE NEEDLE SAMPLE, THE SPECIFIC PROBLEM IS THAT WHEN THE EMERGENCY DEPARTMENT IS RESCUING THE INFUSION, THE Y-PORT NEEDS TO BE PUSHED AND THE SMALL CLIP IS CLOSED. AFTER THE WHITE END CAP IS UNSCREWED, THERE IS BLOOD BACK, AND THE BLOOD FLOWS OUT OF THE WHITE END CAP, CAUSING THE PATIENT TO PANIC. PULL IT OUT DIRECTLY AND RE-PUNCTURE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A LOOSE TUBING CLAMP AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT CAME TO THE HOSPITAL FOR DUE TO HEART FAILURE. DURING THE USE OF BD LIEN NEEDLE, THE CLIP WAS NOT CLOSED COMPLETELY AND THE PATIENT'S BLOOD RETURNED, CAUSING MISUNDERSTANDING AMONG FAMILY MEMBERS AND INCREASING THE RISK OF INFECTION. SO IT WAS CHANGED ANOTHER INDWELLING NEEDLE TO PUNCTURE AFTER EXTUBATION. ON 2020-11-17 RECEIVED AN UPDATE FROM THE SALES REPRESENTATIVE. THE EVENT DESCRIPTION IS UPDATED AS FOLLOWS: FEEDBACK INFORMATION ABOUT THE COMPLAINT IS AS FOLLOWS: MODEL GY IS 22, 383019, BATCH NUMBER, 0140313, AT THAT TIME, THE SITUATION DID NOT TAKE PHOTOS AND THE NEEDLE SAMPLE, THE SPECIFIC PROBLEM IS THAT WHEN THE EMERGENCY DEPARTMENT IS RESCUING THE INFUSION, THE Y-PORT NEEDS TO BE PUSHED AND THE SMALL CLIP IS CLOSED. AFTER THE WHITE END CAP IS UNSCREWED, THERE IS BLOOD BACK, AND THE BLOOD FLOWS OUT OF THE WHITE END CAP, CAUSING THE PATIENT TO PANIC. PULL IT OUT DIRECTLY AND RE-PUNCTURE. ,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441488 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 0140313

    Patients

    Seq Age Sex Outcome Treatment
    1