BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9526306 · Received December 27, 2019

    Report

    Report Number
    3006948883-2019-01130
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    November 29, 2019
    Report Date
    January 16, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO LEAKAGE AS ALL RETENTION SAMPLES MET SPECIFICATIONS. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141678. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON NOVEMBER 29, THE NURSE PLACED THE INDWELLING NEEDLE FOR THE PATIENT'S PUNCTURE. WHEN PUSHING THE MEDICINE, IT WAS FOUND THAT THE LIQUID LEAKED FROM THE SIDE OF THE EXTENSION TUBE. THE NURSE EXPLAINED TO THE PATIENT, AND THE PATIENT UNDERSTOOD AND AGREED TO TAKE OUT THE INDWELLING NEEDLE FOR THE PATIENT, AND PLACED THE INDWELLING NEEDLE FOR THE PATIENT'S SECOND PUNCTURE, THUS SUCCESSFULLY PUSHING THE MEDICINE. THE SECOND PUNCTURE DID HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6), THE NURSE PLACED THE INDWELLING NEEDLE FOR THE PATIENT'S PUNCTURE. WHEN PUSHING THE MEDICINE, IT WAS FOUND THAT THE LIQUID LEAKED FROM THE SIDE OF THE EXTENSION TUBE. THE NURSE EXPLAINED TO THE PATIENT, AND THE PATIENT UNDERSTOOD AND AGREED TO TAKE OUT THE INDWELLING NEEDLE FOR THE PATIENT, AND PLACED THE INDWELLING NEEDLE FOR THE PATIENT'S SECOND PUNCTURE, THUS SUCCESSFULLY PUSHING THE MEDICINE. THE SECOND PUNCTURE DID HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322772 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 9141678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other