Medline URO170814TSQRecalls & reported problems
Medline Industries, Inc. · TRAY CAUTI TEMP SENS MF 14FR 10ML SAFE · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489723496), received between Jan 19, 2023 and Sep 11, 2026 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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
Most reported problems
Device problems
- Fluid/Blood Leak2
- Leak/Splash2
- Unintended Deflation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734280 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699030 ↗InjuryMay 15, 2023Leak/Splash; Leak/Splash
ACCORDING TO THE FACILITY URINE WAS LEAKING AROUND THE CATHETER WHICH REQUIRED THE STAFF TO REMOVE THE CATHETER AND REPLACED IT WITH A NEW CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16930207 ↗InjuryMay 15, 2023Leak/Splash; Leak/Splash
ACCORDING TO THE FACILITY URINE WAS LEAKING AROUND THE CATHETER WHICH REQUIRED THE STAFF TO REMOVE THE CATHETER AND REPLACED IT WITH A NEW CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16930050 ↗InjuryJan 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE CUSTOMER, A PATIENT WAS ADMITTED TO THE HOSPITAL WITH THE FOLEY CATHETER IN PLACE AND IT WAS FOUND TO BE 'LEAKING AT THE INSERTION SITE'. THE CUSTOMER REPORTED AFTER BEING UNSUCCESSFUL WITH TROUBLE SHOOTING TECHNIQUES AN ADDITIONAL CATHETER WAS REQUIRED TO BE INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16211045 ↗
Other Catheter care tray devices
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- Bardia® Foley Catheter Insertion Tray 802010C. R. Bard, Inc. · Catheter care tray54 reports
- Medline DYND10160Medline Industries, Inc. · Catheter care tray1 recall4 reports
- Medline DYNC1816Medline Industries, Inc. · Catheter care tray1 recall2 reports
- Medline DYND10407Medline Industries, Inc. · Catheter care tray1 recall1 report
- SureStep Intermittent Catheter Tray INTAAIC. R. Bard, Inc. · Catheter care tray1 recall1 report
- Medline Industries, Inc. DYNJ65199AMedline Industries, Inc. · Catheter care tray1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.