Dover P4P14TSDRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521066953), received between Sep 18, 2020 and Jan 19, 2021 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 4, 2023Open, Classified

   Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

   Z-1047-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE 14 FR TEMP SENSING FOLEY BECAME DISCONNECTED AT THE TAPED HUB AT A TIME WHEN STAFF WAS NOT IN THE ROOM. THE PROVIDER WAS NOTIFIED AND THE EQUIPMENT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194070 ↗
• MalfunctionJan 4, 2021Disconnection; Disconnection

  CUSTOMER REPORTS: A 14 FRENCH FOLEY CATHETER SPONTANEOUSLY BECAME DISCONNECTED FROM THE GRAVITY DRAINAGE BAG. THE GREEN PLASTIC WAS STILL SURROUNDING THE END OF THE CATHETER. THE FOLEY CATHETER WAS REPLACED USING A STERILE TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11111720 ↗
• MalfunctionNov 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE 14 FR TEMP SENSING FOLEY CAME DISCONNECTED AT THE TAPED HUB WHEN STAFF WERE NOT IN THE ROOM. THE PROVIDER WAS NOTIFIED AND THE DEVICE WAS REPLACED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10828680 ↗
• MalfunctionOct 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLEY CATHETER BECAME DISCONNECTED FROM THE BAG AT THE SEAL. THE CATHETER WAS PLACED ON THE SAME DAY AS THE OCCURRENCE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10750213 ↗
• MalfunctionOct 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER SPONTANEOUSLY BECAME DISCONNECTED FROM THE GRAVITY DRAINAGE BAG. THE GREEN PLASTIC WAS STILL SURROUNDING THE END OF THE CATHETER. THE COVERING PA WAS NOTIFIED AND THE FOLEY CATHETER WAS REPLACED USING STERILE TECHNIQUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734560 ↗
• MalfunctionOct 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BECAME DISCONNECTED FROM THE GRAVITY DRAINAGE BAG SPONTANEOUSLY. THE FOLEY CATHETER WAS LEFT OUT PER PROVIDER ORDER. IT IS NOT KNOWN WHAT DATE THE CATHETER WAS PLACED AS THE PATIENT IS NO LONGER ON THE UNIT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734505 ↗
• MalfunctionOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT TWO FOLEY CATHETERS FELL APART BACK-TO-BACK UPON BEING PLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10693426 ↗
• MalfunctionOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER CAME APART AT THE GREEN SEAL WHERE THE CATHETER CONNECTS TO THE DRAINAGE TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10693373 ↗
• MalfunctionOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER DISCONNECTED WHILE THE TAMPER SEAL REMAINED INTACT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690064 ↗
• MalfunctionOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER DISCONNECTED FROM THE TAMPER RESISTANCE SEAL WHILE THE PATIENT WAS SLEEPING IN BED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10689870 ↗
• MalfunctionSep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED, AFTER AMBULATION, THE PATIENT'S FOLEY WAS FOUND DISCONNECTED WITH THE TAMPER PROOF SEAL STILL INTACT. THE FOLEY DRAINAGE BAG AND THE BLUE CATHETER HAD BECOME SEPARATED; THE TAMPER PROOF SEAL WAS STILL ON THE BLUE PART OF THE FOLEY CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10555319 ↗
• MalfunctionSep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED WHILE AMBULATING WITH A PATIENT, THE FOLEY CATHETER THAT WAS ATTACHED TO THE PATIENT'S LEG BY A SECURE STRIP, BECAME DETACHED WHERE THE RUBBER CATHETER MEETS THE CONNECTING TUBING THAT RUNS TO THE FOLEY BAG. THERE WAS NO FORCE CAUSING THIS TO BECOME DISLODGED. THE RN WAS PRESENT AND AWARE, AND CLEANED AND RE-ATTACHED THE BAG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10554808 ↗