BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 12572431 · Received October 4, 2021

    Report

    Report Number
    3014704491-2021-00179
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 16, 2021
    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 0231208. 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 TUBE WAS FOUND BROKEN WHEN THE NEEDLE HANDLE WAS PULLED BACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AT 08:52 ON (B)(6) 2021, THE INDWELLING NEEDLE WAS USED FOR INFUSION OF PATIENTS IN BED 22. WHEN THE NEEDLE HANDLE WAS PULLED BACK, THE CATHETER TUBE AT THE INDWELLING NEEDLE HEAD WAS FOUND TO BE BROKEN, SO THE INDWELLING NEEDLE WAS REPLACED IMMEDIATELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469090 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ 0231208

    Patients

    Seq Age Sex Outcome Treatment
    1