BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8464492 · Received March 29, 2019

    Report

    Report Number
    3006948883-2019-00221
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 17, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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 REPORT WAS CONDUCTED FOR LOT NUMBER 8233335, AND NO RELATED ABNORMALITIES WERE FOUND. THIS LOT OF INTIMA II WAS MANUFACTURED IN JUNE OF 2018; AND IT WAS DETERMINED THAT THIS IS THE ONLY INSTANCE THIS ISSUE OCCURRING IN THIS BATCH OF PRODUCT. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, A SAMPLE WAS RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION. OUR INVESTIGATORS NOTED A SMALL CRACK WAS FOUND DURING LEAKAGE TESTING THAT WAS LOCATED ON THE ADAPTER. THE RETURNED PRODUCT'S SWAGE DIMENSIONS WERE MEASURED BY OUR TEAM AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. HOWEVER ACCORDING TO PREVIOUS INVESTIGATIONS, THROUGH A VARIANCE IN THE AUTOLINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO APPLY EXCESS FORCE TO THE DEVICE DURING ASSEMBLY, ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE. CURRENTLY, WE ARE CONDUCTING A LONG TERM STUDY TO DETERMINE THE ROOT CAUSE FOR THIS EVENT, CAPA#642738, BUT WE ARE ADDRESSING THE ISSUE THROUGH THE IMPLEMENTATION OF MANUAL INSPECTION S FOR CRACKS IN THE ADAPTER HEAD, AND WE ARE FURTHUR OPTIMIZING OUR SWAGING PROCESS BY REDUCING DEPTH REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿IT WAS FOUND LEAKAGE AT CATHETER JUNCTION DURING PREPRIME."

    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 LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿IT WAS FOUND LEAKAGE AT CATHETER JUNCTION DURING PREPRIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256099 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233335 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Other