BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II

    MDR report key: 9616518 · Received January 22, 2020

    Report

    Report Number
    3006948883-2020-00021
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 19, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 97290346. 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 THE 20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, THE PATIENT NEEDED INTRAVENOUS INFUSION DUE TO THE CUT OF THE ELECTRIC SAW IN HIS LEFT CALF. DURING THE USE OF THE INDWELLING NEEDLE, IT WAS FOUND THAT THE INTERFACE OF THE INDWELLING NEEDLE WAS NOT WELL CONNECTED, LEADING TO FLUID LEAKAGE AND LOCAL SKIN FLUSHING. AS A RESULT, THE INFUSION FAILED, THE INDWELLING NEEDLE WAS REMOVED AND LOCALLY DISINFECTED AND BANDAGED.

    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 THE 20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, THE PATIENT NEEDED INTRAVENOUS INFUSION DUE TO THE CUT OF THE ELECTRIC SAW IN HIS LEFT CALF. DURING THE USE OF THE INDWELLING NEEDLE, IT WAS FOUND THAT THE INTERFACE OF THE INDWELLING NEEDLE WAS NOT WELL CONNECTED, LEADING TO FLUID LEAKAGE AND LOCAL SKIN FLUSHING. AS A RESULT, THE INFUSION FAILED, THE INDWELLING NEEDLE WAS REMOVED AND LOCALLY DISINFECTED AND BANDAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82643 20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 7290346

    Patients

    Seq Age Sex Outcome Treatment
    1 Other