Medline DYND12584Recalls & reported problems
Medline Industries, Inc. · BAG,LEG,COMFORT-STRAPS,MEDIUM,20OZ · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10080196840779), received between Jan 26, 2019 and Sep 30, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
- Improper Flow or Infusion4
- Obstruction of Flow1
Patient problems
- Unspecified Infection5
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949829 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
It was reported that DYND12584H qty 1 was leaking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734279 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693437 ↗MalfunctionApr 24, 2026Fluid/Blood Leak
CUSTOMER STATED, "THE BLUE PART ON THE LEG BAG IS SLOWLY LEAKING."
Patient problems: Insufficient Information
MAUDE report 24983227 ↗MalfunctionJan 27, 2019Improper Flow or Infusion
IT WAS REPORTED THAT THE LEG BAG WAS "NOT DRAINING PROPERLY" AND A PATIENT WAS DIAGNOSED WITH UROSEPSIS.
Patient problems: Unspecified Infection
MAUDE report 8280343 ↗MalfunctionJan 27, 2019Improper Flow or Infusion
IT WAS REPORTED THAT THE LEG BAG WAS "NOT DRAINING PROPERLY" AND A PATIENT WAS DIAGNOSED WITH UROSEPSIS.
Patient problems: Unspecified Infection
MAUDE report 8280338 ↗MalfunctionJan 27, 2019Improper Flow or Infusion
IT WAS REPORTED THAT THE LEG BAG WAS "NOT DRAINING PROPERLY" AND A PATIENT WAS DIAGNOSED WITH UROSEPSIS.
Patient problems: Unspecified Infection
MAUDE report 8280333 ↗MalfunctionJan 26, 2019Obstruction of Flow
IT WAS REPORTED THAT THE LEG BAG WAS "NOT DRAINING PROPERLY" AND A PATIENT WAS DIAGNOSED WITH UROSEPSIS.
Patient problems: Unspecified Infection
MAUDE report 8280282 ↗MalfunctionJan 26, 2019Improper Flow or Infusion
IT WAS REPORTED THAT THE LEG BAG WAS "NOT DRAINING PROPERLY" AND A PATIENT WAS DIAGNOSED WITH UROSEPSIS.
Patient problems: Unspecified Infection
MAUDE report 8280272 ↗
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® Urine Meter with Bag 153214AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 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 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page