BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8913418 · Received August 20, 2019

    Report

    Report Number
    3006948883-2019-00676
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 29, 2019
    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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171142. 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEFECTIVE TUBING WAS FOUND DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER (CHINESE TRANSLATION), "PATIENTS DUE TO "LEFT COARSE FRACTURE, AO31A23 TYPE" ADMITTED TO THE HOSPITAL ON (B)(6)2019 IN ACCORDANCE WITH THE DOCTOR'S INSTRUCTIONS TO PLACE "RETENTION NEEDLE" 17 BEFORE THE 9:30 INFUSION TO FIND THE PATIENT INFUSION SITE THERE IS A BLOOD, AND GRADUALLY INCREASED, IMMEDIATELY STOP, THE BLEEDING SITE DISINFECTION DISPOSAL, THE PATIENT, CHECK THE BODY WITHOUT ABNORMALITY, CONTINUE THE INFUSION AFTER REPLACING THE RETENTION NEEDLE."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT DEFECTIVE TUBING WAS FOUND DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER ((B)(6) TRANSLATION), "PATIENTS DUE TO "LEFT COARSE FRACTURE, AO31A23 TYPE" ADMITTED TO THE HOSPITAL ON (B)(6) 2019 IN ACCORDANCE WITH THE DOCTOR'S INSTRUCTIONS TO PLACE "RETENTION NEEDLE" 17 BEFORE THE 9:30 INFUSION TO FIND THE PATIENT INFUSION SITE THERE IS A BLOOD, AND GRADUALLY INCREASED, IMMEDIATELY STOP, THE BLEEDING SITE DISINFECTION DISPOSAL, THE PATIENT, CHECK THE BODY WITHOUT ABNORMALITY, CONTINUE THE INFUSION AFTER REPLACING THE RETENTION NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707429 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 8171142

    Patients

    Seq Age Sex Outcome Treatment
    1 Other