BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13232711 · Received January 11, 2022

    Report

    Report Number
    3006948883-2021-01052
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 13, 2021
    Report Date
    January 30, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230655. 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 H10.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS BROKEN WHILE USING BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE PATIENT EXPERIENCED BLEEDING, HOWEVER, THERE WAS NO SERIOUS INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN THE INDWELLING NEEDLE WAS SEALED, IT WAS FOUND THAT THE TRANSPARENT CATHETER TUBE OF THE INDWELLING NEEDLE WAS BROKEN AND THE PATIENT HAD VENOUS BLEEDING. THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED AND STOPPED BLEEDING WITH COTTON SWABS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS BROKEN WHILE USING BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE PATIENT EXPERIENCED BLEEDING, HOWEVER, THERE WAS NO SERIOUS INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE INDWELLING NEEDLE WAS SEALED, IT WAS FOUND THAT THE TRANSPARENT CATHETER TUBE OF THE INDWELLING NEEDLE WAS BROKEN AND THE PATIENT HAD VENOUS BLEEDING. THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED AND STOPPED BLEEDING WITH COTTON SWABS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941312 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1230655

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown