Medline DYND140218Recalls & reported problems

Medline Industries, Inc. · TRAY,FOLEY,SILVER,2-WAY,18FR,10ML,LF · Class 1

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

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196183401), received between Nov 26, 2018 and Mar 8, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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.

Most reported problems

Device problems

Complete Blockage1
Physical Resistance/Sticking1

Patient problems

No Consequences Or Impact To Patient1
Unspecified Tissue Injury1

Recent adverse event reports

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

InjuryMar 8, 2022Physical Resistance/Sticking
IT WAS REPORTED BY THE FACILITY THAT THE CATHETER, 'ADHERES TO THE TISSUE CAUSING PAINFUL REMOVAL AND TISSUE DAMAGE' RESULTING IN ANOTHER CATHETER BEING REINSERTED.
Patient problems: Unspecified Tissue Injury
MAUDE report 13685792 ↗
MalfunctionNov 26, 2018Complete Blockage
IT WAS REPORTED THAT THE URINARY CATHETER'S DRAINAGE BAG "CLOGGED" WITH SEDIMENT AND THE URINARY CATHETER WAS REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8102081 ↗

Device details

UDI-DI	`10080196183401`
Brand	Medline
Model	DYND140218
Company	Medline Industries, Inc.
Product code	EYZ · SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE
Class	Class 1
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	Dec 4, 2020

Device type (GMDN): Indwelling urethral catheterization kit, adult

A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Other SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE devices

Medline DYND10820
Medline Industries, Inc. · SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE
2 reports
Medline DYND140214
Medline Industries, Inc. · SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE
2 reports

All SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE devices →

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
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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