BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15891103 · Received November 30, 2022

    Report

    Report Number
    3014704491-2022-00614
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    November 3, 2022
    Report Date
    December 5, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2172309. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY 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 H10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. 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 · 0

    IT WAS REPORTED THAT SMALL HOLES WERE FOUND IN THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE HEAD NURSE OF THE PEDIATRIC DEPARTMENT REPORTED THAT WHEN THE PRODUCT WAS INSPECTED BEFORE USE, IT WAS FOUND THAT THERE WERE WHITE SPOTS ON THE HOSE AND IT WAS SUSPECTED THAT IT WAS A HOLE;"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SMALL HOLES WERE FOUND IN THE BD INTIMA-II CLOSED IV CATHETER SYSTEM BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE HEAD NURSE OF THE PEDIATRIC DEPARTMENT REPORTED THAT WHEN THE PRODUCT WAS INSPECTED BEFORE USE, IT WAS FOUND THAT THERE WERE WHITE SPOTS ON THE HOSE AND IT WAS SUSPECTED THAT IT WAS A HOLE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961234 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2172309 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown