BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20 GA X 1-3/4 IN SINGLE PORT

    MDR report key: 11572696 · Received March 25, 2021

    Report

    Report Number
    1710034-2021-00236
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    February 25, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835188
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-03-29 H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED NEXIVA CATHETER ASSEMBLY WITH A NEEDLELESS CONNECTOR. UPON INSPECTION OF THE RECEIVED UNIT, IT WAS OBSERVED THAT THE EXTENSION TUBING WAS BALLOONED NEAR THE CONNECTION TO THE WINGED ADAPTER CONFIRMING THE REPORTED DEFECT. THE IFU STATES THE MAXIMUM POWER INJECTOR PRESSURE LIMIT SETTING OF 300 PSI. THE REPORTED PRESSURE USED WAS 325 PSI WHICH WAS ABOVE SPECIFICATION. NO OTHER DAMAGE WAS NOTED TO THE UNIT INDICATING THAT EXCEEDING SPECIFICATION LIKELY RESULTED IN THE BALLOONING OF THE EXTENSION TUBING. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 20 GA X 1-3/4 IN SINGLE PORT TUBING EXPANDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383518 BATCH NO.: 0063597 IT WAS REPORTED THAT NEXIVA TUBING EXPANDED SIGNIFICANTLY, BUT DID NOT RUPTURE. PER EMAIL: 1. DATE OF OCCURRENCE: 2/25/21, REPORTED TO ME ON 3/1/21 1. PLACEMENT DATE: (B)(6) 2021 2. EXPLANT DATE: (B)(6) 2021 3. PLACEMENT INFO: UNKNOWN 4. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: TEGADERM 5. A DETAILED DESCRIPTION OF THE EVENT: DEVICE PLACED USING ULTRASOUND FOR AN OUTPATIENT CT. EXCELLENT BLOOD RETURN ON INSERTION. CT RAN AT 325 PSI 4ML/SEC USING OMNIPAQUE 350, CTA OF CHEST/ABDOMEN/PELVIS. SCAN DID NOT COMPLETE AND TUBING ON NEXIVA EXPANDED SIGNIFICANTLY RIGHT BEFORE THE PINK PLATFORM, BUT DID NOT RUPTURE. CT HAS BEEN NOTIFIED THAT NEXIVA IS RATED AT A MAX OF 300 PSI. 6. WAS THERE PATIENT HARM REPORTED?:NO

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 20 GA X 1-3/4 IN SINGLE PORT TUBING EXPANDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383518 BATCH NO.: 0063597. IT WAS REPORTED THAT NEXIVA TUBING EXPANDED SIGNIFICANTLY, BUT DID NOT RUPTURE. PER EMAIL: DATE OF OCCURRENCE: (B)(6) 2021, REPORTED TO ME ON 3/1/21. PLACEMENT DATE: (B)(6) 2021. EXPLANT DATE: (B)(6) 2021. PLACEMENT INFO: UNKNOWN. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: TEGADERM. A DETAILED DESCRIPTION OF THE EVENT: DEVICE PLACED USING ULTRASOUND FOR AN OUTPATIENT CT. EXCELLENT BLOOD RETURN ON INSERTION. CT RAN AT 325 PSI 4ML/SEC USING OMNIPAQUE 350, CTA OF CHEST/ABDOMEN/PELVIS. SCAN DID NOT COMPLETE AND TUBING ON NEXIVA EXPANDED SIGNIFICANTLY RIGHT BEFORE THE PINK PLATFORM, BUT DID NOT RUPTURE. CT HAS BEEN NOTIFIED THAT NEXIVA IS RATED AT A MAX OF 300 PSI. WAS THERE PATIENT HARM REPORTED?:NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468585 NEXIVA 20 GA X 1-3/4 IN SINGLE PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0063597 00382903835188

    Patients

    Seq Age Sex Outcome Treatment
    1