MEDLINE DYND15405Recalls & reported problems
Medline Industries, Inc. · BAG,DRAINAGE,4L,A/R TOWER,METAL CLAMP · Class 2
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10080196993406), received between Jul 23, 2024 and Sep 30, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 Leak7
- Material Puncture/Hole3
- Crack2
- Appropriate Device Problem Term/Code Not Available1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Anxiety1
- Cramp(s) /Muscle Spasm(s)1
- Fever1
- Insufficient Information1
- Nausea1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949232 ↗MalfunctionSep 30, 2026Crack
It was reported that "connected foley catheter drainage bag to foley and noted drainage spout is cracked and leaking. RN went to replace drainage bag and noted all bags in PACU are similarly cracked."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941745 ↗MalfunctionSep 30, 2026Crack; Material Puncture/Hole
It was reported that "THE BLUE RUBBER HOSE CONNECTOR HAS VISIBLE HOLES AND LOOKS WEATHERED/WORN OUT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941679 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926659 ↗MalfunctionSep 25, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903925 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that BAG IS NOT HEAT SEALED AND LEAKED ALL OVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882353 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported that items has a leakage near the valve.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870025 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847838 ↗MalfunctionSep 12, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746762 ↗MalfunctionMay 7, 2026Fluid/Blood Leak
CUSTOMER STATED, WE HAVE HAD PREVIOUSLY BEFORE AND JUST YESTERDAY HAD A URINARY DRAINAGE BAG LEAK OF ITEM DYN15405 IN A PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 25113963 ↗InjuryJul 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, " FROM THE LATTER PART OF (B)(6) OF 2024, THE NURSES WERE USING THE BAGS FROM THE NEWER MEDLINE PRODUCTS. SOON, URINE WAS GUSHING BACK INTO MY BLADDER. I SUFFERED INTENSE BLADDER SPASMS, UNBEARABLE PAIN, NAUSEA,FEVER AND ENDED UP WITH A SERIOUS BLADDER INFECTION."
Patient problems: Anxiety; Cramp(s) /Muscle Spasm(s); Fever; Nausea; Pain; Unspecified Infection
MAUDE report 19810932 ↗
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.