MEDLINE INDUSTRIES, INC. DYND160806TRecalls & reported problems
Medline Industries, Inc. · 1LYR 6FR1.5ML 100%SIL TMP PEDS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889942148226), received between Aug 26, 2024 and Sep 21, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Sensing Problem1
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Bacterial Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Fluid/Blood Leak; Material Puncture/Hole; Device Sensing Problem
It was reported that "Over this past year, we have had 4 6 Fr temp sensing foleys malfunction. The temperature sensing metal looking part stopping working and then it is found that the foley itself is punctured by it, found by urine leaking."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838252 ↗InjuryJun 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
FOLEY CATHETER "TESTED POSTIIVE FOR E. COLI".
Patient problems: Bacterial Infection
MAUDE report 22350300 ↗MalfunctionAug 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON 07/31/2024 THE SAMPLE PORT DETACHED, AND THE PATIENT REQUIRED A NEW CATHETER TO BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20070933 ↗
Other Catheter care tray devices
- Centurion Medical Products Corp CVI680CMedline Industries, Inc. · Catheter care tray2 recalls0 reports
- Medline Industries, Inc. DYNJ81597Medline Industries, Inc. · Catheter care tray2 recalls0 reports
- 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
- SureStep Intermittent Catheter Tray INTAAIC. R. Bard, Inc. · Catheter care tray1 recall1 report
- Medline DYND10407Medline Industries, Inc. · Catheter care tray1 recall1 report
- MEDLINE URO4RR16CMedline Industries, Inc. · Catheter care tray1 recall0 reports
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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