Extension Tubing 650615Recalls & reported problems

C. R. Bard, Inc. · Extension Tubing, For use with Male External Catheters · 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 00801741050978), received between Jun 6, 2017 and Jun 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 Operates Differently Than Expected1

Patient problems

Alteration In Body Temperature1
Skin Irritation1

Recent adverse event reports

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

InjuryJun 6, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE EXTENSION TUBING ALLEGEDLY CAUSED BLISTERING. THE PATIENT IS CURRENTLY USING A PRESCRIBED CREAM FROM HIS PHYSICIAN.
Patient problems: Alteration In Body Temperature; Skin Irritation
MAUDE report 6616435 ↗

Device details

UDI-DI	`00801741050978`
Brand	Extension Tubing
Model	650615
Company	C. R. Bard, Inc.
Product code	NNW · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 10, 2022

Device type (GMDN): Penis wearable urinal

An externally-worn urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag. The device is intended to provide an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention, and eliminates the need for groin and waist straps. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Other BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE devices

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3 reports
Conveen Security+ 21346
Coloplast A/S · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE
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All BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-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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