BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 20316050 · Received September 26, 2024

    Report

    Report Number
    3002601200-2024-00467
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 24, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER: 4081463. 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 SINGLE DEVICE WAS RETURNED TO AID IN OUR INVESTIGATION. THE NEEDLE AND CATHETER WERE INVESTIGATED BY VISUAL AND FUNCTIONAL ANALYSIS FOR PENETRATION. THE RETURNED DEVICE WAS FOUND TO BE VISUAL AND FUNCTIONAL CONSISTENT WITH PRODUCT SPECIFICATION AND FREE OF ANY ABNORMALITIES. THE REPORTED DIFFICULTY WITH PENETRATION COULD NOT BE CONFIRMED. ADDITIONALLY, OUR ENGINEERS OBSERVED THE PRESENCE OF BLOOD AT THE LOCATION OF THE SEPTUM OF THE DEVICE. CLOSER INSPECTION OF THE SEPTUM WAS NOT ABLE TO IDENTIFY ANY KNOWN ISSUES WITH THE SEPTUM THAT WOULD HAVE LED TO THE OBSERVED LEAK. OUR ENGINEERS WERE NOT ABLE TO IDENTIFY THE ROOT CAUSE FOR LEAKAGE AT THIS TIME AND ARE CURRENTLY CONDUCTING AN IN-DEPTH CAPA INVESTIGATION INTO ALL POTENTIAL CAUSES. THIS PROCESS WILL TAKE TIME AND WE APPRECIATE YOUR PATIENCE. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED. THE PATIENT HAD A FEVER FOR 1 DAY AND WAS DIAGNOSED WITH ACUTE UPPER RESPIRATORY TRACT INFECTION. HE WAS TREATED WITH INFUSION IN THE OUTPATIENT CLINIC. ON (B)(6) 2024, DURING THE INSERTION OF THE INDWELLING NEEDLE, THE NEEDLE WAS NOT INSERTED SMOOTHLY, AND BLOOD OVERFLOWED FROM THE NEEDLE CORE HOLE WHEN IT WAS PULLED OUT, RESULTING IN THE FAILURE OF THE INDWELLING NEEDLE PUNCTURE. A NEW INDWELLING NEEDLE WAS REPLACED AND THE PUNCTURE WAS SUCCESSFUL AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739192 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) INCORRECT ENTRY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown