BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13619270 · Received February 28, 2022

    Report

    Report Number
    3014704491-2022-00077
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    January 17, 2022
    Report Date
    February 10, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230658. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230658. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE CONNECTION BETWEEN THE ADAPTER AND TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "BEFORE USING THE NEEDLE FOR VENIPUNCTURE ON (B)(6) 2022. (B)(6), THE INFUSION SET WAS CONNECTED TO THE INDWELLING NEEDLE TO DRAIN THE AIR IN THE INDWELLING NEEDLE. FLUID LEAKAGE WAS FOUND AT THE CONNECTION BETWEEN THE EXTENSION TUBE AND THE TWO FORKING TUBES. THE INDWELLING NEEDLE WAS REPLACED IMMEDIATELY WITHOUT ANY ADVERSE CONSEQUENCES FOR THE CHILD."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE CONNECTION BETWEEN THE ADAPTER AND TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "BEFORE USING THE NEEDLE FOR VENIPUNCTURE ON (B)(6) 2022. (B)(6), THE INFUSION SET WAS CONNECTED TO THE INDWELLING NEEDLE TO DRAIN THE AIR IN THE INDWELLING NEEDLE. FLUID LEAKAGE WAS FOUND AT THE CONNECTION BETWEEN THE EXTENSION TUBE AND THE TWO FORKING TUBES. THE INDWELLING NEEDLE WAS REPLACED IMMEDIATELY WITHOUT ANY ADVERSE CONSEQUENCES FOR THE CHILD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905754 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1230658

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown