BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT WITH MAXZERO, 22G X 1.0"

    MDR report key: 15351713 · Received September 2, 2022

    Report

    Report Number
    9610847-2022-00339
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 6, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903835522
    PMA / PMN Number
    K170336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL: YES. D.9. RETURNED TO MANUFACTURER ON: 06-SEP-2022. H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE OPENED 22G X 1.00IN NEXIVA DEVICE FROM LOT NUMBER 2122512. IN ADDITION, TWO PHOTOGRAPHS WERE SUBMITTED WHICH DISPLAYED THE UNIT WITH A PULLED NEEDLE IN THE SAFETY SHIELD WITH THE CATHETER ADAPTER STILL ATTACHED TO THE TIP SHIELD. THROUGH THE VISUAL INSPECTION OF THE SAMPLE RETURNED, NO VISIBLE DEFECTS WERE OBSERVED. THE UNIT WAS THEN REENGAGED AND RETRACTED TO TRY TO RECREATE THE REPORTED ISSUE. THROUGH OUR TESTING A FULL RETRACTION WAS OBSERVED, AND THE CATHETER ADAPTER DECOUPLED FROM THE TIP SHIELD AFTER SEVERAL TRIALS. FURTHER EVALUATION OF ALL THE PARTS DISPLAYED ADHESIVE PRESENT ON THE CATHETER ADAPTER AND THE TIP SHIELD. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO EXCESSIVE ADHESIVE BEING DISPENSED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA SINGLE PORT WITH MAXZERO, 22G X 1.0" THE SAFETY MECHANISM WOULD NOT DISENGAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383552, BATCH NO: 2122512. IT WAS REPORTED BY CUSTOMER THAT "THE GREY AND WHITE PIECE WOULD NOT DISENGAGE OFF THE SEPTUM PIECE." SINGLE PORT WAS USED FOR DEMO PURPOSES. DURING THE DEMO, THE BD NURSE IN-SERVICING, THE GREY AND WHITE PIECE WOULD NOT DISENGAGE OFF THE SEPTUM PIECE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA SINGLE PORT WITH MAXZERO, 22G X 1.0" THE SAFETY MECHANISM WOULD NOT DISENGAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383552. BATCH NO: 2122512. IT WAS REPORTED BY CUSTOMER THAT "THE GREY AND WHITE PIECE WOULD NOT DISENGAGE OFF THE SEPTUM PIECE." , SINGLE PORT WAS USED FOR DEMO PURPOSES. DURING THE DEMO, THE BD NURSE IN-SERVICING , THE GREY AND WHITE PIECE WOULD NOT DISENGAGE OFF THE SEPTUM PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381934 BD NEXIVA SINGLE PORT WITH MAXZERO, 22G X 1.0" INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2122512 00382903835522

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown