BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12283116 · Received August 5, 2021

    Report

    Report Number
    1710034-2021-00663
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 7, 2021
    Report Date
    August 23, 2021
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1063618. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A 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. ADDITIONALLY, PHOTOGRAPHS WERE SUBMITTED TO AID IN OUR INVESTIGATION INTO THIS INCIDENT. OUR ENGINEERS NOTED THAT THE PHOTOGRAPHS DISPLAYED A NEEDLE BENT AT THE NOTCH POSITION AND A PIERCED CATHETER TUBE. BASED ON CLOSER INSPECTION OF THE PROVIDED PHOTOGRAPHS, OUR ENGINEERS BELIEVE THAT THIS ISSUE MAY BE THE RESULT OF REINSERTION DURING USE. IN THE PROVIDED PHOTOGRAPHS THE TIP OF THE CATHETER TUBING IS SATURATED WITH BLOOD. THIS INDICATES THAT THE TUBING WAS INVOLVED WITH THE INITIAL INSERTION AND A PARTIAL INTUBATION. BOTH A CATHETER-SPEAR-THROUGH AND A BENT NEEDLE CAN OCCUR DURING THE MANUFACTURING PROCESS, HOWEVER BOTH NON-CONFORMANCES WOULD RESULT IN AN INOPERABLE DEVICE THAT IS INCAPABLE OF A PARTIAL INTUBATION LIKE THE ONE OBSERVED IN THE PROVIDED PHOTOGRAPH. BASED ON THE AVAILABLE INFORMATION OUR ENGINEERS HAVE DETERMINED THAT THIS NON-CONFORMANCE IS UNRELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A NEEDLE THROUGH THE CATHETER DURING CATHETER INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MORNING, ONE OF MY SHORT STAY STAFF INSERTED ONE OF THE BD NEXIVA ON A PATIENT. AFTER GETTING BLOOD RETURN, SHE HAD A BIT OF RESISTANCE AND WENT TO REPOSITION. THE PATIENT COMPLAINED OF SIGNIFICANT DISCOMFORT. SHE REMOVED THE IV AND THE NEEDLE WAS SEPARATED FROM THE PLASTIC SHEATH AND PARTIALLY BENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A NEEDLE THROUGH THE CATHETER DURING CATHETER INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MORNING, ONE OF MY SHORT STAY STAFF INSERTED ONE OF THE BD NEXIVA ON A PATIENT. AFTER GETTING BLOOD RETURN, SHE HAD A BIT OF RESISTANCE AND WENT TO REPOSITION. THE PATIENT COMPLAINED OF SIGNIFICANT DISCOMFORT. SHE REMOVED THE IV AND THE NEEDLE WAS SEPARATED FROM THE PLASTIC SHEATH AND PARTIALLY BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180106 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ 383536 1063618 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1