Merit Drainage Depot™ 00884450008256Recalls & reported problems

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 00884450008256), received between Dec 26, 2019 and Dec 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Emits Odor” (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

Device Emits Odor1

Patient problems

Nausea1
No Code Available1

Recent adverse event reports

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

InjuryDec 26, 2019Device Emits Odor
NAUSEA AND LOSS OF APPETITE DUE TO PERSISTENT FOUL ODOR. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Nausea; No Code Available
MAUDE report 9525211 ↗

Device details

UDI-DI	`00884450008256`
Brand	Merit Drainage Depot™
Model	00884450008256
Company	Merit Medical Systems, Inc.
Product code	EXF · BAG, BILE COLLECTING
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	Apr 25, 2025

Device type (GMDN): Closed-wound/centesis drainage receptacle

A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Other BAG, BILE COLLECTING devices

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Merit Drainage Depot™ 00884450025604
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1 report

All BAG, BILE COLLECTING 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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