BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9437602 · Received December 9, 2019

    Report

    Report Number
    3006948883-2019-01042
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    June 25, 2019
    Report Date
    December 17, 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 SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171151. 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 WAS NOT RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION, 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 (CAPA 642738) TO DETERMINE THE ROOT CAUSE FOR THIS EVENT, BUT WE ARE ADDRESSING THE ISSUE THROUGH THE IMPLEMENTATION OF MANUAL INSPECTIONS FOR CRACKS IN THE ADAPTER HEAD, AND WE ARE FURTHER OPTIMIZING OUR SWAGING PROCESS BY REDUCING DEPTH REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH LEAKAGE AT THE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ACCORDING TO THE DOCTOR'S ADVICE, THE PATIENT WAS PLACING NEEDLE WHICH IS GOOD FOR THE INFUSION TREATMENT, THE PATIENT ON (B)(6) 2019, THE NURSE RIPPED PACKAGE WITH GOOD CONDITION, DURING THE EFFECTIVE PERIOD, THE Y TYPE, 0.7 THE X19MM NEEDLE FOR THE PATIENTS IN THE PROCESS, WAS FOUND TO HAVE BLOOD LEAKAGE WITH HARD CONNECTING PIPE, AFTER CAREFUL OBSERVATION, IT WAS FOUND THAT THERE WAS A LITTLE CRACK, THE NURSE IMMEDIATELY UNPLUGGED THE NEEDLE, AND EXPLAINED TO THE PATIENT, THEN REPLACED THE NEEDLE FOR PATIENT'S INFUSION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH LEAKAGE AT THE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ACCORDING TO THE DOCTOR'S ADVICE, THE PATIENT WAS PLACING NEEDLE WHICH IS GOOD FOR THE INFUSION TREATMENT, THE PATIENT ON (B)(6) 2019, THE NURSE RIPPED PACKAGE WITH GOOD CONDITION, DURING THE EFFECTIVE PERIOD, THE Y TYPE, 0.7 THE X19MM NEEDLE FOR THE PATIENTS IN THE PROCESS, WAS FOUND TO HAVE BLOOD LEAKAGE WITH HARD CONNECTING PIPE, AFTER CAREFUL OBSERVATION, IT WAS FOUND THAT THERE WAS A LITTLE CRACK, THE NURSE IMMEDIATELY UNPLUGGED THE NEEDLE, AND EXPLAINED TO THE PATIENT, THEN REPLACED THE NEEDLE FOR PATIENT'S INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237015 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8171151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other