Extension Tubing 150615Recalls & 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: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741050824), received between May 16, 2017 and Feb 17, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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

Component Missing1
Kinked1
No Device Output1
Restricted Flow rate1

Patient problems

No Clinical Signs, Symptoms or Conditions1
No Consequences Or Impact To Patient1
No Information1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 17, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE HOSE WAS MISSING IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16395864 ↗
MalfunctionSep 25, 2018Restricted Flow rate; No Device Output; Restricted Flow rate
IT WAS REPORTED THAT THE URINE WAS STAYING IN THE EXTENSION TUBING.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7906028 ↗
MalfunctionMay 16, 2017Kinked
IT WAS REPORTED THAT THE TUBING ALLEGEDLY BECAME KINKED
Patient problems: No Information
MAUDE report 6571346 ↗

Device details

UDI-DI	`00801741050824`
Brand	Extension Tubing
Model	150615
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

Extension Tubing 650615
C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE
1 report
Conveen Security+ 21346
Coloplast A/S · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE
1 report

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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