BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9432388 · Received December 6, 2019

    Report

    Report Number
    3006948883-2019-01040
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 14, 2019
    Report Date
    January 2, 2020
    Manufacturer
    BD (SUZHOU)
    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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7110121. 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 DEFECTIVE CATHETER WAS FOUND DURING USE WITH A 20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN GIVING INFUSION TO THE PATIENT ON (B)(6) 2019, IT WAS FOUND THAT THE FRONT END OF THE CLOSED INTRAVENOUS INDWELLING NEEDLE HOSE WAS IN THE SHAPE OF A CURL, AND THE IMMEDIATE REPLACEMENT DID NOT AFFECT THE PATIENT."

    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 DEFECTIVE CATHETER WAS FOUND DURING USE WITH A 20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN GIVING INFUSION TO THE PATIENT ON (B)(6) 2019, IT WAS FOUND THAT THE FRONT END OF THE CLOSED INTRAVENOUS INDWELLING NEEDLE HOSE WAS IN THE SHAPE OF A CURL, AND THE IMMEDIATE REPLACEMENT DID NOT AFFECT THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228984 20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 7110121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other