BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9981376 · Received April 21, 2020

    Report

    Report Number
    3006948883-2020-00142
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 31, 2020
    Report Date
    May 14, 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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9170856 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. PHOTOS WERE SUBMITTED FOR EVALUATION. YELLOW FLUID FOREIGN MATTER WAS SEEN IN THE PHOTO. 30 PCS OF THE RETAINED SAMPLES WERE TESTED AND NO ABNORMALITIES WERE OBSERVED. 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 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. IT WAS FOUND THAT SOME YELLOW FLUID WERE ON THE INDWELLING NEEDLE, AND THE NEEDLE HAD NOT BEEN PUNCTURED AND IT DID NOT CAUSE ANY HARM TO THE PATIENT. 2. THE SALES REP HAD GIVEN THE CLAIM PRODUCT TO THE HOSPITAL, AND THE REP NEEDED GREEN CLAIM.

    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 BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND THAT SOME YELLOW FLUID WERE ON THE INDWELLING NEEDLE, AND THE NEEDLE HAD NOT BEEN PUNCTURED AND IT DID NOT CAUSE ANY HARM TO THE PATIENT. THE SALES REP HAD GIVEN THE CLAIM PRODUCT TO THE HOSPITAL, AND THE REP NEEDED GREEN CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443840 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 9170856

    Patients

    Seq Age Sex Outcome Treatment
    1 Other