BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8476081 · Received April 2, 2019

    Report

    Report Number
    3006948883-2019-00239
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 12, 2019
    Report Date
    May 9, 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

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8141417. 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. ADDITIONALLY , ALTHOUGH A SAMPLE COULD NOT BE PROVIDED, OUR ENGINEERS WERE ABLE TO DETERMINE, THROUGH PREVIOUS INVESTIGATIONS, THAT THE ROOT CAUSE FOR THIS EVENT IS AN OVERSIZED COMPONENT FOUND ON THE INTERIOR OF THE ADAPTER HOUSING. WE ARE ADDRESSING THE ISSUE THROUGH THE IMPLEMENTATION OF MANUAL INSPECTION S FOR CRACKS IN THE ADAPTER HEAD, WE ARE OPTIMIZING OUR SWAGING PROCESS BY INCREASING THE DEPTH OF HOUSING CAVITIES TO ACCOMMODATE THE COMPONENT, AND WORKING WITH COMPONENT MANUFACTURES TO REDUCE THE AVERAGE SIZE OF THE AFFECTED COMPONENT. CAPA#642738 HAS BEEN INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD BLOOD LEAKAGE FROM THE NEEDLE BODY PART. FOREIGN COMPLAINTS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ¿ IT WAS FOUND BLOOD LEAKAGE AT NEEDLE BODY PART, THEN CHANGE A NEW ONE. ¿

    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 A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD BLOOD LEAKAGE FROM THE NEEDLE BODY PART. FOREIGN COMPLAINTS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ¿ IT WAS FOUND BLOOD LEAKAGE AT NEEDLE BODY PART, THEN CHANGE A NEW ONE. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269732 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8141417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other