Dover 7000Recalls & reported problems
Cardinal Health, Inc. · Urine Meter,Luer-Slip Sampling · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521002173), received between Aug 11, 2022 and Nov 22, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (5 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
- Obstruction of Flow5
- Improper Flow or Infusion3
Patient problems
- Discomfort3
- No Clinical Signs, Symptoms or Conditions3
- Pain3
- Urinary Retention2
- Chills1
- Fever1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2023Improper Flow or Infusion; Improper Flow or Infusion
THE CUSTOMER REPORTED IN THE MULTI-PURPOSE INTENSIVE CARE UNIT, IT WAS FOUND THE URINE WAS NOT FLOWING IN THE DEVICE. THIS PROBLEM IS RECURRENT ACCORDING TO THE HEALTH CARE TEAM. THIS INCIDENT CAUSES DISCOMFORT AND PAIN TO THE PATIENTS AND PUT THEM AT RISK OF URINARY GLOBES.
Patient problems: Discomfort; Pain
MAUDE report 18192834 ↗MalfunctionNov 22, 2023Improper Flow or Infusion; Improper Flow or Infusion
THE CUSTOMER REPORTED ON (B)(6) 2023, IN THE MULTI-PURPOSE INTENSIVE CARE UNIT, IT WAS FOUND THE URINE WAS NOT FLOWING ON A 74 YEAR OLD. THIS INCIDENT CAUSED DISCOMFORT AND PAIN TO THE PATIENT AND PUT THEM AT RISK OF URINARY GLOBES.
Patient problems: Discomfort; Pain
MAUDE report 18192723 ↗MalfunctionNov 22, 2023Improper Flow or Infusion; Improper Flow or Infusion
THE CUSTOMER REPORTED ON 01/11/2023, IN THE MULTI-PURPOSE INTENSIVE CARE UNIT, IT WAS FOUND THE URINE WAS NOT FLOWING ON A 58 YEAR OLD. THIS INCIDENT CAUSED DISCOMFORT AND PAIN TO THE PATIENT AND PUT THEM AT RISK OF URINARY GLOBES.
Patient problems: Discomfort; Pain
MAUDE report 18192591 ↗MalfunctionNov 21, 2023Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT THE URINE WASN'T LEAKING. THERE WAS NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT URINE DID NOT FLOW FROM THE TUBE AFTER URINARY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18187370 ↗MalfunctionNov 16, 2023Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT THE URINE WASN'T LEAKING. THERE WAS NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT URINE DID NOT FLOW FROM THE TUBE AFTER URINARY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18154782 ↗MalfunctionMay 5, 2023Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THE NURSES ARE FORCED TO EMPTY THE TUBING EVERY TWO HOURS BECAUSE IT DOESN'T FLOW INTO THE POCKET CAUSING A PROBLEM TO QUANTIFY URINE. THERE WAS NO PATIENT INJURY OR DEATH AND THE TIME OF THE PROCEDURE WAS NOT LONGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16880485 ↗MalfunctionApr 11, 2023Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED, IF YOU DON'T PUT IT ON THE GROUND, THE URINE STAGNATES IN THE BLADDER AND DOESN'T GO DOWN INTO THE BOX.
Patient problems: Urinary Retention
MAUDE report 16712793 ↗MalfunctionAug 11, 2022Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT THE URINE METER DOES NOT DRAIN PROPERLY. THE PATIENT HAS FREQUENT URINARY RETENTION. THE CABINET OF THE URINE METER DOES NOT EMPTY WELL WHEN TILTED. THE BAG PULLS A VACUUM WHICH CAUSES THE CASING NOT TO EMPTY. PER ADDITIONAL INFORMATION PROVIDED ON AUGUST 09, 2022, THIS ISSUE HAS OCCURRED WITH SEVERAL PATIENTS. THE AMOUNT OF URINE RETAINED HAS RANGED FROM 300 TO 500 ML. THE PATIENTS HAVE BEEN TREATED BY BLADDER FLUSHING AND FOLIATION. THERE WERE NO MEDICATIONS PRESCRIBED AS A RESULT OF THE RETENTION AS IT WAS CLEAR THE PROBLEM WAS WITH THE DRAINAGE FROM THE CATHETER. ASSUMING THAT THIS PROBLEM HAS EXISTED FOR SOME TIME, PATIENT'S HAVE DISPLAYED SYMPTOMS OF FEVERS, CHILLS, AND NOT FEELING WELL. ALSO ASSUMING THAT THIS PROBLEM HAS EXISTED FOR SOME TIME, PATIENTS HAVE BEEN RECATHETERIZED, EVEN UP TO THREE TIMES. ON CT, FULL BLADDER, BUT DESCENDING CATHETER. PER ADDITIONAL INFORMATION PROVIDED ON 10AUG2022, FOLIATION IS REFERRING TO THE EMPTYING OF THE BLADDER. IT IS UNKNOWN EXACTLY HOW MANY PATIENTS HAVE BEEN INVOLVED.
Patient problems: Chills; Fever; Urinary Retention
MAUDE report 15210717 ↗
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.