MEDLINE DYND15205Recalls & reported problems
Medline Industries, Inc. · BAG,DRAINAGE,ANTI-REFLUX TOWER,2000ML · Class 2
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10080196828685), received between Apr 29, 2026 and Sep 30, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (42 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 Leak42
- Material Puncture/Hole4
- Material Split, Cut or Torn2
- Crack1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Ambulation or Postural Difficulties1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that "SHE WORE THIS TO BED,SHE WOKE UP TO A MESS. IT WAS LEAKING SOMEWHERE EVEN WHILE UPRIGHT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947024 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936733 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935015 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Material Split, Cut or Torn
It was reported that the drain bag was "TORN ON SIDE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915126 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
It was reported that ¿Bags are leaking.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914972 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902912 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
It was reported that the product begins leaking after a few uses.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897656 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
It was reported that "CUST PURCHASED ONE LAST YEAR AND LEAKED AND HE PURCHASED ONE AGAIN LAST MONTH AND LEAKED ALL OVER HIS CARPET."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896221 ↗MalfunctionSep 25, 2026Material Puncture/Hole
It was reported that "Cust received damaged product. These arrived with pin holes in them."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896113 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860419 ↗MalfunctionSep 19, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831850 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821611 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820697 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
It was reported that "HER LAST 3 DRAINAGE BAGS WERE LEAKING."
Patient problems: Ambulation or Postural Difficulties
MAUDE report 50818590 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809095 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792878 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
It was reported that "his urinary drain bag was leaking" and "its leaking all over his bed and home."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789784 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781122 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
It was reported that "LEAKING AT TOP OF BAG. WHEN THE BAG LAYS FLAT THE LIQUID LEAKED OUT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760035 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
It was reported that 5 bags DYND15205H are leaking will not hold urine at all.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757496 ↗MalfunctionSep 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747620 ↗MalfunctionSep 12, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746768 ↗MalfunctionSep 12, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746324 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717106 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694731 ↗
Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices
- Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber 802001C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER117 reports
- Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154002C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153214AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153204C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER106 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A399400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 recalls0 reports
- Bard® Urinary Drainage Bag 153509C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER91 reports
- Bard® Urinary Drainage Bag 153504C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER89 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.