Medline DYND140216Recalls & reported problems
Medline Industries, Inc. · TRAY,FOLEY,SILVER,2-WAY,16FR,10ML,LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196183418), received between Nov 26, 2018 and Sep 8, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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. 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
- Complete Blockage2
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
- Material Discolored1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Material Discolored
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672145 ↗MalfunctionSep 8, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668684 ↗InjuryFeb 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER ON (B)(6) 2024 THE CATHETER BALLOON RUPTURED INSIDE THE PATIENT REQUIRING THE FOLEY CATHETER TO BE REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18659469 ↗InjuryMay 2, 2019Material Rupture
IT WAS REPORTED THAT DURING PLACEMENT OF AN INDWELLING CATHETER THE BALLOON THAT WAS PLACED IN THE PATIENT RUPTURED WITHIN A FEW MINUTES OF THE BALLOON OF THE CATHETER BEING INFLATED. A NEW URINARY CATHETER WAS REQUIRED TO BE INSERTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8575338 ↗MalfunctionNov 26, 2018Complete Blockage
IT WAS REPORTED THAT THE URINARY CATHETER'S DRAINAGE BAG "CLOGGED" WITH SEDIMENT AND THE URINARY CATHETER WAS REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8103426 ↗MalfunctionNov 26, 2018Complete Blockage
IT WAS REPORTED THAT THE URINARY CATHETER'S DRAINAGE BAG "CLOGGED" WITH SEDIMENT AND THE URINARY CATHETER WAS REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8101938 ↗
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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