Dover P4P16TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884521057736), received between Feb 3, 2021 and Jun 16, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE FOLEY CATHETER SPONTANEOUSLY DISCONNECTED FROM THE URINE COLLECTION BAG. THE FOLEY CATHETER WAS REPLACED AND THE PROVIDERS WERE MADE AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012478 ↗
• MalfunctionJun 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE FOLEY CATHETER CAME APART UNDER THE GREEN SEAL. THE FOLEY HAD TO BE REMOVED AND REPLACED. THE PATIENT HAD TO HAVE AN ADDITIONAL UNCOMFORTABLE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012073 ↗
• MalfunctionJun 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE FOLEY WAS PLACED IN THE EMERGENCY DEPARTMENT; A FEW HOURS AFTER ARRIVAL TO ICU FOLEY NOTED TO BE DISCONNECTED. THE TAMPER SEAL WAS STILL INTACT AND NO FORCE HAD BEEN APPLIED TO THE TUBING. THE FOLEY WAS REMOVED (UNKNOWN LOT #) AND REPLACED WITH NEW FOLEY.

  Patient problems: Insufficient Information

  MAUDE report 12011879 ↗
• MalfunctionJun 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE PATIENT'S FOLEY WAS FOUND TO BE DISCONNECTED AT THE HUB. THE FOLEY WAS REMOVED AND REPLACED PER PROTOCOL.

  Patient problems: Insufficient Information

  MAUDE report 12011469 ↗
• MalfunctionJun 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE PATIENT PRESSED CALL LIGHT TO INFORM RN THAT FOLEY CATHETER TUBING HAD DISCONNECTED. THE PATIENT WAS SITTING IN BED, HOLDING THE DISTAL, FOLEY BAG TUBING IN HAND, WITH THE PROXIMAL TUBING STILL ATTACHED TO THE COMMERCIAL LEG STRAP WITH TUBING SECUREMENT TAPE FULLY INTACT. PATIENT REPORTS SHE MOVED SLIGHTLY IN THE BED AND THE TUBING DETACHED. THERE WAS NO URINE NOTED ON LINEN AND THE FOLEY BAG CONTAINED 300CC OF CLEAR YELLOW URINE. THE FOLEY WAS IMMEDIATELY REMOVED AND DOCUMENTED BY RN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011209 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE 16 FR FOLEY CATHETER GOT DISCONNECTED, BREAKING STERILITY. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11965964 ↗
• MalfunctionFeb 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CATHETER DISCONNECTED FROM THE TUBING AT THE GREEN TAPE WHILE IN USE WITH A PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272542 ↗
• MalfunctionFeb 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CATHETER DISCONNECTED FROM THE TUBING AT THE GREEN TAPE WHILE IN USE WITH A PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272523 ↗
• MalfunctionFeb 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CATHETER DISCONNECTED FROM THE TUBING AT THE GREEN TAPE WHILE IN USE WITH A PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272426 ↗
• MalfunctionFeb 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CATHETER DISCONNECTED FROM THE TUBING AT THE GREEN TAPE WHILE IN USE WITH A PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272393 ↗