Medline DYND50428Recalls & reported problems

Medline Industries, Inc. · PENROSE DRAIN 18 X .5" SILICONE · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884389119419), received between Sep 5, 2024 and Sep 5, 2024 — classified as 1 injury.

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.

Most reported problems

Device problems

Appropriate Device Problem Term/Code Not Available1

Patient problems

Foreign Body Reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE DURING A ROBOTIC HIATAL HERNIA CASE THE "DRAIN SNAPPED INSIDE OF A PATIENT".
Patient problems: Foreign Body Reaction
MAUDE report 20146056 ↗

Device details

UDI-DI	`10884389119419`
Brand	Medline
Model	DYND50428
Company	Medline Industries, Inc.
Product code	GBW · CATHETER, PERITONEAL
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	Feb 1, 2023

Device type (GMDN): Surgical capillary wound drain, luminal, synthetic polymer

A sterile device with a lumen(s) designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically made of radiopaque silicone and is available in various forms (e.g., Penrose type, tubular with side holes, multi-tubular). This is a single-use device.

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All CATHETER, PERITONEAL 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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