BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER

    MDR report key: 15620747 · Received October 17, 2022

    Report

    Report Number
    3014704491-2022-00489
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    September 21, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    30382903833468
    PMA / PMN Number
    K923702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUTION? YES. D.9. RETURNED TO MANUFACTURER ON: 04-OCT-2022 H.6. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1041999. 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 WAS SUBMITTED TO AID IN OUR INVESTIGATION , UNFORTUNATELY DUE TO THE CURRENT CUSTOMS LAW IN CHINA, USED MEDICAL DEVICES CANNOT BE IMPORTED TO THE FACILITY OF MANUFACTURE. TO MITIGATE THE AFFECT THIS HAS ON OUR INVESTIGATION, HIGH RESOLUTION MAGNIFIED PHOTOGRAPHS WERE TAKEN OF THE DEVICE AND SUBMITTED TO OUR ENGINEERS FOR REVIEW. OUR ENGINEERS WERE NOT ABLE TO IDENTIFY ANY CHARACTERISTIC DAMAGE OR DEFORMITIES ON THE SURFACE OF THE DEVICE THAT WOULD CONTRIBUTED TO THE REPORTED LEAKAGE. ADDITIONALLY, FUNCTIONAL TESTING WAS PERFORMED ON THE RETENTION SAMPLES FOR THE AFFECTED LOT. TEST RESULTS INDICATE THAT THE RETAINED DEVICES WERE FREE OF ANY NONCONFORMANCE AND OPERATED WITHIN PRODUCT PARAMETERS. UNFORTUNATELY WITHOUT THE ABILITY TO OBSERVE OR REPLICATE THE REPORTED NON-CONFORMANCE OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER EXPERIENCED LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE USED THE DEVICE AS A RETURN LINE CATHETER TO A PATIENT DURING A PERIPHERAL ACCESS APHERESIS PROCEDURE. THE FLOW RATE WAS ABOUT 30ML/MIN (WHICH INCLUDES THE ¿RETURN¿ BLOOD FLOW FROM THE APHERESIS MACHINE PLUS A CALCIUM GLUCONATE INFUSION, WHICH WAS CONNECTED TO THE ADDITIONAL PORT ON THE CATHETER). THE ISSUE WAS DISCOVERED WHEN THE PATIENT RAISED HIS ARM TO SHOW THAT THERE WAS BLOOD RUNNING DOWN HIS ARM AND THE DRESSING TO SECURE THE IV SITE WAS SATURATED. THE APHERESIS COLLECTION PROCEDURE WAS PAUSED AND THE SITE WAS UNDRESSED AND CLEANED TO ASSESS WHERE THE BLOOD WAS COMING FROM. THE CATHETER ITSELF WAS IN PLACE AND WAS NOT LEAKING FROM THE VENIPUNCTURE SITE BUT WAS NOTED TRICKLING WHERE THE CATHETER CONNECTS TO THE WINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER EXPERIENCED LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE USED THE DEVICE AS A RETURN LINE CATHETER TO A PATIENT DURING A PERIPHERAL ACCESS APHERESIS PROCEDURE. THE FLOW RATE WAS ABOUT 30ML/MIN (WHICH INCLUDES THE ¿RETURN¿ BLOOD FLOW FROM THE APHERESIS MACHINE PLUS A CALCIUM GLUCONATE INFUSION, WHICH WAS CONNECTED TO THE ADDITIONAL PORT ON THE CATHETER). THE ISSUE WAS DISCOVERED WHEN THE PATIENT RAISED HIS ARM TO SHOW THAT THERE WAS BLOOD RUNNING DOWN HIS ARM AND THE DRESSING TO SECURE THE IV SITE WAS SATURATED. THE APHERESIS COLLECTION PROCEDURE WAS PAUSED AND THE SITE WAS UNDRESSED AND CLEANED TO ASSESS WHERE THE BLOOD WAS COMING FROM. THE CATHETER ITSELF WAS IN PLACE AND WAS NOT LEAKING FROM THE VENIPUNCTURE SITE BUT WAS NOTED TRICKLING WHERE THE CATHETER CONNECTS TO THE WINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351525 BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 383346 1041999 30382903833468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown