DeRoyal 71-C606Recalls & reported problems

Deroyal Industries, Inc. · Tubing Suction Connector · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756579117), received between Feb 6, 2025 and Feb 6, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Seal” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Failure to Seal1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionFeb 6, 2025Failure to Seal; Failure to Seal
A USER FACILITY REPORTED THAT THE 6MM TUBING WAS OBSERVED HAVING DIFFICULT WITH SECUREMENT OF ITEMS WITHIN THE "GRIP" OF THE CONNECTOR PERSISTED ON ALL OF THE TUBING SKUS IN THEIR INVENTORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21327163 ↗

Device details

UDI-DI	`00749756579117`
Brand	DeRoyal
Model	71-C606
Company	Deroyal Industries, Inc.
Product code	BYY · TUBE, ASPIRATING, FLEXIBLE, CONNECTING
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	Aug 31, 2021

Device type (GMDN): Suction/irrigation tubing, single-use

A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.