BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 11402640 · Received March 2, 2021

    Report

    Report Number
    3006948883-2021-00272
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    January 25, 2021
    Report Date
    February 12, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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 0202485. 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. ALTHOUGH A VIDEO WAS SUBMITTED FOR EVALUATION,A PHYSICAL 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. INVESTIGATION CONCLUSION: LEAK OCCURRED AT THE CONNECTION BETWEEN THE INDWELLING NEEDLE EXTENSION TUBE AND THE Y-ADAPTER DURING INFUSION. CHECKED THE BATCH RECORD OF THIS LOT, NO ABNORMAL FOUND ON IN-PROCESS INSPECTION, FG INSPECTION AND MACHINE TROUBLESHOOTING RECORDS. LEAKAGE TEST THE 2 RETAINED SAMPLES, ALL PASSED. NO SAME COMPLAINT WAS RECEIVED FROM THE COMPLAINT LOT. NO DEFECTIVE SAMPLE RETURNED, AND NO ABNORMAL FOUND ON PROCESS. THE ROOT CAUSE OF THE LEAKAGE AT THE JUNCTION BETWEEN THE INDWELLING EXTENSION TUBE AND THE Y-ADAPTER COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II" CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT 16:40, ON (B)(6) 2021, ACCORDING TO THE PATIENT'S CONDITION NEEDS TO USE THE INDWELLING NEEDLE INFUSION TREATMENT, DURING THE USE OF THE INDWELLING NEEDLE, IT WAS FOUND DAMAGED, LEAKAGE, IMMEDIATELY STOP THE USE OF THE DISCOVERY, TO REPLACE THE NEW INDWELLING NEEDLE, NO HARM TO THE PATIENT. ON (B)(6) 2021 RECEIVED SALES REPRESENTATIVE UPDATE, EVENT DESCRIPTION UPDATE AS FOLLOWS: NO ADVERSE EVENT WAS CAUSED TO THE PATIENT, ONLY THE PAIN OF THE SECOND PUNCTURE WAS CAUSED. HOWEVER, THE DEFECTIVE INDWELLING NEEDLE HAS BEEN DISPOSED OF AND THE SAMPLE CANNOT BE RETURNED, SO THE BATCH NUMBER AND PHOTO OF THE INDWELLING NEEDLE CANNOT BE OBTAINED, BUT THE VIDEO AND ARTICLE NUMBER OBTAINED FROM THE HEAD NURSE ARE DETERMINED TO BE 383033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295200 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0202485

    Patients

    Seq Age Sex Outcome Treatment
    1