BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 16772244 · Received April 19, 2023

    Report

    Report Number
    3014704491-2023-00128
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 18, 2023
    Report Date
    April 6, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    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

    H6: INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2082645. 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. H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA II¿ IV CATHETER PRN ADAPTER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PARTURIENT WAS ADMITTED TO THE HOSPITAL AT 37 WEEKS OF PREGNANCY DUE TO A SCARRED UTERUS, AND UNDERWENT CESAREAN SECTION ACCORDING TO THE DOCTOR'S ADVICE. WHEN PREPARING FOR THE OPERATION, AN INTRAVENOUS INDWELLING NEEDLE WAS USED TO ESTABLISH A VENOUS CHANNEL. AFTER THE PUNCTURE WAS SUCCESSFUL, THE INFUSION SET WAS CONNECTED, AND IT WAS FOUND THAT THE CONNECTION OF THE VENOUS INDWELLING NEEDLE WAS LEAKING, AND THE INFUSION TREATMENT COULD NOT BE PERFORMED NORMALLY, SO IT WAS REMOVED IMMEDIATELY, REPLACED AND RE-PUNCTURED, AND A NEW VENOUS CHANNEL WAS ESTABLISHED. AFTER RE-PUNCTURE, NORMAL INFUSION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766012 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2082645 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown