Medline DYND27403SRecalls & reported problems

Medline Industries, Inc. · METER,URINE,400ML,DRAIN BAG,L/F,LL,SLIDE · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10080196749577), received between Sep 10, 2026 and Sep 10, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Fluid/Blood Leak1

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.

MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716190 ↗

Device details

UDI-DI	`10080196749577`
Brand	Medline
Model	DYND27403S
Company	Medline Industries, Inc.
Product code	FFG · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
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	Mar 29, 2018

Device type (GMDN): Urethral/ureteral catheter connector, sterile

A small, sterile, connecting device intended to create a mechanical union between the proximal end of urethral and/or ureteral catheter and an external device (e.g., irrigation/vacuum unit, syringe, urine drainage bag) to enable infusion, drainage, or other procedures to be performed through the lumen of the catheter; it has no additional functions (e.g., not a two-way valve). It may also be intended to connect a urinary condom catheter (a penis sheath-type catheter) to a urine drainage bag. This is a single-use device.

Other DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE devices

Dover P4P16XTSD
Cardinal Health 200, LLC · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
77 reports
Dover P4P16TSD
Cardinal Health 200, LLC · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
61 reports
Dover P4P16TS
Cardinal Health, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
10 reports
Dover P4P16XTS
Cardinal Health, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
10 reports
Dover P4P16SD
Cardinal Health 200, LLC · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
9 reports
Medline DYND17407L
Medline Industries, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
2 reports
Dover P4P18TS
Cardinal Health, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
2 reports
Medline DYND27403
Medline Industries, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
1 report

All DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page