MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA; INTRAVASCULAR CATHETER

Catalog Number	383511
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that the iv with nexiva catheter upon obtaining blood return, blood began leaking out of cannula before able to advance fully into vein.Tip of cannula inside of vein also started pointing upward causing skin to tent as pushing forward to advance into vein.Noted hole on side of iv cannula and crooked cannula upon removal.Complaint via email.Medical device incident report to vendor request for investigation and complaints/lot review mdip # (b)(4) device available for investigation: yes please see the below device problem report.There was no serious harm reported.The device is available for investigation (additional details below).Mdip report: incident or problem information mdip reference number (id): (b)(4) date of incident (yyyy-mm-dd): (b)(6) 2026 type of incident/problem: a2.Failure (i.E.While preparing for, in use, after use) level of harm: temporary harm.Optional report to cmdsnet (health canada): incident details: initiating iv with nexiva catheter upon obtaining blood return, blood began leaking out of cannula before able to advance fully into vein.Tip of cannula inside of vein also started pointing upward causing skin to tent as pushing forward to advance into vein.Noted hole on side of iv cannula and crooked cannula upon removal.Procedure: peripheral iv initiation.Device information device name/description: catheter iv passive safety non-winged closed system singe port yellow 24gx19mm nexiva.Manufacturer: becton dickinson canada inc manufacturer code/model: 383511 serial or lot number: (b)(6) expiry date: 2028-05-31.Supplier: supplier/catalogue number: 333-383511 is the device retained? yes number of devices: 1 wiped, contained, labelled? wiped, doubled bagged (if consumable), and labelled as per instructions.Device handling hazards blood and/or body fluid contaminated | cytotoxic, chemotherapy or hazardous medication.Investigation request expected type of investigation: actual device tested; lot review.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issues of catheter tip integrity, catheter defective/ damaged and leakage were confirmed upon inspection of the sample.Analysis of the sample showed the catheter tip was damaged.The catheter tubing had a puncture mark that caused the leak near the adapter.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.A simulation was carried out where the cannula was reinserted while the catheter was partially in the tubing.This simulation was done during a flashback test.It was observed that reinsertion of the cannula will lead to leakage from the catheter tubing.The leak was consistent with the returned sample.There was no abnormality during the production run based on the device history record review.Based on the returned sample, the cannula pierced through the catheter.However, the puncture was successfully recreated with another sample by puncturing the cannula halfway through the catheter tubing.The mark recreated has the same characteristic as the returned sample.As mentioned in the instructions for use (ifu); if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur.The catheter tip was observed damaged from the returned sample.There are vision systems in place to check and ensure the tipping of the catheter is within specification.The damaged observed on the returned sample may be from the user application process.

• Brand Name: NEXIVA
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24927313
• Report Number: 2243072-2026-00289
• Device Sequence Number: 10671068
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: (01)00382903835119(11)250626(17)280531(10)5177054
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 383511
• Device Lot Number: 5177054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown