BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 22GAX1.00IN PRN SLM NPVC

    MDR report key: 9648260 · Received January 30, 2020

    Report

    Report Number
    3006948883-2020-00042
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    November 28, 2019
    Report Date
    February 26, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141582. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DAMAGED PACKAGE WAS FOUND BEFORE USE WITH A INTIMA-II 22GAX1.00IN PRN SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PATIENT HAD DEEP VEIN THROMBOSIS IN THE LOWER EXTREMITY. IN THE EARLY MORNING OF (B)(6) THE PATIENT UNDERWENT VENOUS ANGIOGRAPHY OF THE LOWER EXTREMITY IN THE EMERGENCY DEPARTMENT. WHEN THE INDWELLING NEEDLE WAS PRESET, IT WAS FOUND THAT THERE WAS DAMAGE AND AIR LEAKAGE IN THE OUTER PACKAGE, WHICH COULD NOT ENSURE THAT THE INSTRUMENT WAS SEALED AND STERILE. REPLACED IT."

    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 DAMAGED PACKAGE WAS FOUND BEFORE USE WITH A INTIMA-II 22GAX1.00IN PRN SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PATIENT HAD DEEP VEIN THROMBOSIS IN THE LOWER EXTREMITY. IN THE EARLY MORNING OF (B)(6), THE PATIENT UNDERWENT VENOUS ANGIOGRAPHY OF THE LOWER EXTREMITY IN THE EMERGENCY DEPARTMENT. WHEN THE INDWELLING NEEDLE WAS PRESET, IT WAS FOUND THAT THERE WAS DAMAGE AND AIR LEAKAGE IN THE OUTER PACKAGE, WHICH COULD NOT ENSURE THAT THE INSTRUMENT WAS SEALED AND STERILE. REPLACED IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113782 INTIMA-II 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141582

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other