BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.56IN PRN/PRN SLM NPVC

    MDR report key: 9535780 · Received December 31, 2019

    Report

    Report Number
    3006948883-2019-01146
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 2, 2019
    Report Date
    January 24, 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

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7234118. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEPARIN CAP FELL OFF THE INTIMA-II Y 24GAX0.56IN PRN/PRN SLM NPVC DURING USE AFTER THE INFUSION OF ANTI-INFECTION MEDICATION. THE CATHETER WAS USED ON A CHILD PATIENT ADMITTED TO THE HOSPITAL FOR PNEUMONIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON (B)(6) 2019, THE CHILD WAS ADMITTED TO HOSPITAL FOR THE DIAGNOSIS OF PNEUMONIA, AND THE PATIENT WAS TREATED WITH INTRAVENOUS INFUSION FOR ANTI-INFECTION. AFTER THE INFUSION OF LIQUID TO SEAL THE TUBE, THE HEPARIN CAP FELL OFF BY ITSELF, AND THE NEW NEEDLE WAS RE-PUNCTURED DUE TO CONTAMINATION".

    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 THE HEPARIN CAP FELL OFF THE INTIMA-II Y 24GAX0.56IN PRN/PRN SLM NPVC DURING USE AFTER THE INFUSION OF ANTI-INFECTION MEDICATION. THE CATHETER WAS USED ON A CHILD PATIENT ADMITTED TO THE HOSPITAL FOR PNEUMONIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2019, THE CHILD WAS ADMITTED TO HOSPITAL FOR THE DIAGNOSIS OF PNEUMONIA, AND THE PATIENT WAS TREATED WITH INTRAVENOUS INFUSION FOR ANTI-INFECTION. AFTER THE INFUSION OF LIQUID TO SEAL THE TUBE, THE HEPARIN CAP FELL OFF BY ITSELF, AND THE NEW NEEDLE WAS RE-PUNCTURED DUE TO CONTAMINATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331578 INTIMA-II Y 24GAX0.56IN PRN/PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 7234118

    Patients

    Seq Age Sex Outcome Treatment
    1 Other