BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II IV CATHETER PRN ADAPTER

    MDR report key: 12586844 · Received October 6, 2021

    Report

    Report Number
    3014704491-2021-00184
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    August 29, 2021
    Report Date
    September 17, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050858. 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 THAT THE BD INTIMA II¿ IV CATHETER PRN ADAPTER WAS DAMAGED DURING THE HIGH-PRESSURE CONTRAST INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2021, THE PATIENT WENT TO THE RADIOLOGY DEPARTMENT FOR ENHANCED CT EXAMINATION OF THE WHOLE ABDOMEN. WHEN THE NURSE INJECTED DRUGS, THE HIGH-PRESSURE SYRINGE REPORTED AN EMERGENCY ERROR. THE NURSE IMMEDIATELY SUSPENDED INFUSION AND CHECKED THE PATIENT'S CONDITION. AFTER CHECKING, THE NURSE FOUND THAT THE INDWELLING NEEDLE WAS DAMAGED... CONTRAST AGENT WAS INJECTED WITH A HIGH-PRESSURE SYRINGE WITHOUT ANY OTHER MEDICAL DEVICE COMBINATION." "IT IS A HIGH FREQUENCY INJECTION, BUT THE SPECIFIC PRESSURE VALUE IS NOW UNCERTAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480827 BD INTIMA II IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1051539

    Patients

    Seq Age Sex Outcome Treatment
    1