Medline DYND10820Recalls & reported problems

Medline Industries, Inc. · KIT,SPECI-CATH,NEONATAL,5FR,PVP,LUB,GLV · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196028894), received between Oct 18, 2021 and Sep 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Filling Problem” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Filling Problem1
Improper or Incorrect Procedure or Method1
Therapeutic or Diagnostic Output Failure1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

MalfunctionSep 30, 2026Filling Problem; Improper or Incorrect Procedure or Method
It was reported that "We are still encountering problems with the 5 & 8 Fr cath tubes not filling up but then the patient ends up urinating around the tube."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946435 ↗
MalfunctionOct 18, 2021Therapeutic or Diagnostic Output Failure
IT WAS REPORTED, A PATIENT WAS CATHETERIZED AN ADDITIONAL TIME DUE TO A REPORT OF A MALFUNCTION IN A CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647117 ↗

Device details

UDI-DI	`10080196028894`
Brand	Medline
Model	DYND10820
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 DYND140218
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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