BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC

    MDR report key: 11463355 · Received March 11, 2021

    Report

    Report Number
    3006948883-2021-00284
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 9, 2021
    Report Date
    March 2, 2021
    Manufacturer
    BD (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 · 1

    INITIAL REPORTER PHONE: (B)(6). INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140318. 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 · 1

    IT WAS REPORTED THAT A INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC LEAKED AND WAS FOUND TO BE DAMAGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ON (B)(6) 2021, AT 10:30, PRE-OPERATION FARCE INDWELLING NEEDLE PUNCTURE, THE NEEDLE AFTER BLOOD VISIBLE IN THE TUBE FROM INDWELLING NEEDLE SEAT JOINT IS ABOUT 0.5 CM HAVE BLOOD TO LEAK OUT, IN ORDER TO AVOID INDWELLING NEEDLE TUBE RUPTURE WITHIN THE BLOOD VESSELS, THE NURSE IMMEDIATELY PULL OUT THE NEEDLE INJECTION, CALM, CHILDREN FOR FAMILIES OF CHILDREN WITH UNEXPLAINED, PUNCTURE AGAIN. AND INFORM THE HEAD NURSE OF THE DEPARTMENT. ADR# (B)(4). ON 2021-02-18 RECEIVED UPDATE, INCIDENT DESCRIPTION UPDATED AS FOLLOWS: AT 10:30 ON (B)(6) 2021, 24G RUIMA INDWELLING NEEDLE PUNCTURE WAS PERFORMED ON THE CHILD. AFTER THE NEEDLE WAS INSERTED AND THE BLOOD RETURNED, IT WAS SEEN THAT AT THE LOCATION OF CATHETER TUBING OF 0.5 CM AWAY FROM THE ADAPTOR, THERE WAS BLOOD LEAKING. IN ORDER TO AVOID CATHETER TUBING BROKEN IN THE BLOOD VESSEL, THE INJECTION NURSE IMMEDIATELY PULLED OUT THE INDWELLING NEEDLE, COMFORTED THE CHILD, EXPLAINED TO THE FAMILY OF THE CHILD, AND RE-PUNCTURED. AND NOTIFY THE HEAD NURSE OF THE DEPARTMENT. ADR# (B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359009 INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0140318

    Patients

    Seq Age Sex Outcome Treatment
    1