Medline Industries, Inc. DYNJRA9040Recalls & reported problems

Medline Industries, Inc. · TRAY 18G CPNB 20G STYLETED · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489830514), received between Jul 27, 2022 and Mar 19, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Oct 16, 2024Class IIOpen, Classified
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Z-0509-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
May 18, 2023Class IIOpen, Classified
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2156-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Obstruction of Flow1

Patient problems

Dyspnea1
Low Blood Pressure/ Hypotension1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 19, 2026Obstruction of Flow
ACCORDING TO THE CUSTOMER CONTACT ON (B)(6) 2026, "THE CATHETER WENT IN WITHOUT INCIDENT, BUT WHEN THE PACU NURSE ATTACHED THE PAIN PUMP IT WAS ALARMING OCCLUSION" AND "PLASTIC POKING OUT OF THE END OF CATHETER". THE CUSTOMER CONTACT STATED, "WE REMOVED THE CATHETER AND PLACED ANOTHER ONE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638479 ↗
InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE FACILITY ON (B)(6) 2022 AN EPIDURAL WAS PLACED AND THE PATIENT EXPERIENCED DIZZINESS, HYPOTENSION, AND DIFFICULTY BREATHING REQUIRING RESCUE BREATHS AND MEDICAL INTERVENTION.
Patient problems: Dyspnea; Low Blood Pressure/ Hypotension
MAUDE report 15113418 ↗

Device details

UDI-DI	`10193489830514`
Brand	Medline Industries, Inc.
Model	DYNJRA9040
Company	Medline Industries, Inc.
Product code	OFT · Spinal epidural anesthesia kit
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 19, 2022

Device type (GMDN): General surgical procedure kit, medicated

A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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