BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 12755990 · Received November 6, 2021

    Report

    Report Number
    3014704491-2021-00240
    Event Type
    Malfunction
    Date Received
    November 6, 2021
    Date of Event
    September 19, 2021
    Report Date
    October 14, 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
    Health Professional
    Yes

    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 LEAKED FROM THE END CAP DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE PATIENT UNDERWENT LAPAROSCOPIC PARTIAL RESECTION OF THE LEFT KIDNEY MASS, AND POSTOPERATIVE SYMPTOMATIC FLUID REPLENISHMENT WAS FOUND. WHEN THE INDWELLING NEEDLE WAS USED TO DRAIN THE FLUID DURING INTRAVENOUS INFUSION AT 9:00 ON (B)(6) 2021, THE END CAP LEAKAGE WAS FOUND, WHICH WAS IMMEDIATELY REPLACED WITHOUT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653938 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1051529

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown