BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9554594 · Received January 6, 2020

    Report

    Report Number
    3006948883-2019-01177
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 27, 2020
    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 SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141678. 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 PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, THE CHILD NURSE IN THE (B)(6) HOSPITAL FELT THAT THE PUNCTURE HAD GREAT RESISTANCE AND WAS NOT SMOOTH. AT THE SAME TIME, THE PATIENT HAD VERY PAINFUL FEELING, AND THEN THE INDWELLING NEEDLE WAS REMOVED. EXAMINATION OF THE INDWELLING NEEDLE REVEALED A WHITE FLOCCULENT MATTER ON THE CATHETER. THE PROBLEMATIC INDWELLING NEEDLE HAD BEEN DISPOSED OF AND NO SAMPLE OF THE SUSPECTED PROBLEM HAD BEEN SENT FOR EXAMINATION, BUT A PHOTOGRAPH REMAINED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, THE CHILD NURSE IN THE DEPARTMENT OF HEMATOLOGY OF THE 14TH FLOOR OF (B)(6) HOSPITAL FELT THAT THE PUNCTURE HAD GREAT RESISTANCE AND WAS NOT SMOOTH. AT THE SAME TIME, THE PATIENT HAD VERY PAINFUL FEELING, AND THEN THE INDWELLING NEEDLE WAS REMOVED. EXAMINATION OF THE INDWELLING NEEDLE REVEALED A WHITE FLOCCULENT MATTER ON THE CATHETER. THE PROBLEMATIC INDWELLING NEEDLE HAD BEEN DISPOSED OF AND NO SAMPLE OF THE SUSPECTED PROBLEM HAD BEEN SENT FOR EXAMINATION, BUT A PHOTOGRAPH REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18858 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 9141678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other