BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13892528 · Received March 24, 2022

    Report

    Report Number
    3014704491-2022-00115
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    February 27, 2022
    Report Date
    April 1, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    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

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230564. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN OPENING THE PACKAGING OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THE NEEDLE PENETRATED THE NEEDLE COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER THE DEVICE PACKAGING WAS OPENED, THE NEEDLE AND SHIELD WERE FOUND TILTED AND THE NEEDLE PUNCTURED THE SHIELD. IT WAS IMMEDIATELY REPLACED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN OPENING THE PACKAGING OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THE NEEDLE PENETRATED THE NEEDLE COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER THE DEVICE PACKAGING WAS OPENED, THE NEEDLE AND SHIELD WERE FOUND TILTED AND THE NEEDLE PUNCTURED THE SHIELD. IT WAS IMMEDIATELY REPLACED.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330311 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1230564

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown