Bardex® Lubricath® Temperature Sensing Foley Catheter 119416MRecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00801741046148), received between Apr 27, 2017 and Sep 9, 2026 — classified as 9 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Deformation Due to Compressive Stress

  Patient problems: Exposure to Body Fluids

  MAUDE report 50702131 ↗
• MalfunctionJul 15, 2026Material Twisted/Bent

  It was reported by customer that after placing Temperature Sensing Foley Catheter the RN discovered that the temperature probe appeared damaged and/or crushed. The foley catheter was removed, and a new foley catheter was placed that had a functional temperature probe. The patient experienced discomfort due to the removal and replacement of the foley catheter. There is no known harm to the patient at this time.Per customer via email on (b)(6) 2026 the lot number is NGLQ0447 and serial number (b)(6). Upon discovery of the temp probe being damaged and nonfunctional, the foley catheter had to be removed and replaced. This caused a delay in care and discomfort to the patient due to the removal and replacement of the catheter.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 25826332 ↗
• MalfunctionApr 1, 2026Unclear Information

  IT WAS REPORTED THAT THE CUSTOMER REACHED OUT REGARDING AN IMPORTANT PRODUCT DISCREPANCY FOR THE BARD TEMPERATURE SENSING CATHETER, PRODUCT #119416M UNDER CONTRACT #(B)(4). THE OUTER PACKAGING INDICATES THE CATHETER HAS A 5CC BALLOON, WHILE THE CATHETER ITSELF IS LABELED 10CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758838 ↗
• InjuryMar 18, 2026Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAD BEEN DEFLATED WITH 10 CC PRIOR TO REMOVAL. THE WRITER HAD ATTEMPTED TO REMOVE THE FOLEY CATHETER AT THE BEDSIDE, BUT RESISTANCE HAD BEEN ENCOUNTERED AT THE MEATUS OF PENIS. THE WRITER NOTIFIED THE CHARGE NURSE, AND WITH THE CHARGE NURSE¿S ASSISTANCE, ATTEMPTED TO READVANCE THE CATHETER AND REMOVE IT AGAIN; HOWEVER, RESISTANCE HAD AGAIN BEEN MET. THE PHYSICIAN ASSISTANT WAS NOTIFIED, AND THE FOLEY WAS LEFT IN PLACE. THE FOLEY CATHETER WAS LATER REMOVED BY THE PHYSICIAN ASSISTANT WITH SUPPORT FROM THE UROLOGY SERVICE, THOUGH THIS REMOVAL WAS NOT WITNESSED BY THE WRITER. AFTER REMOVAL, THE PATIENT HAD REPORTED 9/10 PAIN, AND A SMALL AMOUNT OF BLOOD DRAINAGE HAD BEEN NOTED DURING ASSESSMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 24633254 ↗
• InjuryFeb 25, 2026Difficult to Remove

  IT WAS REPORTED THAT THEY HAD 3 ISSUES NOW WITHIN THE LAST 1.5 TO 2 WEEKS WITH MONO THERM FOLEY CATHETERS BEEN VERY HARD TO REMOVE AND NOT ALLOWING BLADDER EMPTYING. THE MANUFACTURER NUMBER WAS A119416M AND LOT NUMBER IS NGKX5727. FROM WHAT WAS WRITTEN IN THEIR INTERNAL REPORTING MEMO, FOLEY WAS ORDERED TO BE REMOVED AND THE NURSE, AFTER MULTIPLE ATTEMPTS AT DRAINING THE BALLOON, CALLED UROLOGY TO HAVE IT REMOVED. THE FOLEY WAS EVENTUALLY REMOVED WITH SOME FORCE APPLIED BY UROLOGY. (LOT NGKX5727) AND (LOT UNK).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24448081 ↗
• InjuryFeb 25, 2026Difficult to Remove

  IT WAS REPORTED THAT THEY HAD 3 ISSUES NOW WITHIN THE LAST 1.5 TO 2 WEEKS WITH MONO THERM FOLEY CATHETERS BEEN VERY HARD TO REMOVE AND NOT ALLOWING BLADDER EMPTYING. THE MANUFACTURER NUMBER WAS A119416M AND LOT NUMBER IS NGKX5727. FROM WHAT WAS WRITTEN IN THEIR INTERNAL REPORTING MEMO, FOLEY WAS ORDERED TO BE REMOVED AND THE NURSE, AFTER MULTIPLE ATTEMPTS AT DRAINING THE BALLOON, CALLED UROLOGY TO HAVE IT REMOVED. THE FOLEY WAS EVENTUALLY REMOVED WITH SOME FORCE APPLIED BY UROLOGY. (LOT NGKX5727) AND (LOT UNK).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24448065 ↗
• InjuryDec 3, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THERE HAVE SINCE BEEN 3 MORE EVENTS WITH THE SIMILAR SITUATION WHERE THE FOLEY WAS NOT DRAINING APPROPRIATELY. PATIENTS HAVE BEEN BLADDER SCANNED AND FOUND TO HAVE URINE IN THEIR BLADDERS OR EXCHANGE OCCURS AND URINE FLOWS. PER CUSTOMER FOLLOW UP RECEIVED VIA EMAIL ON 04DEC2025 STATED THAT THEY DID BELIEVE THE DEVICE WAS DISCARDED AND 1 MAY HAVE BEEN PICKED UP BY CLINICAL ENGINEERING. PATIENT RETAINED URINE AND ALL DEVICES HAD TO BE REMOVED AND REPLACED TO ALLOW URINE TO FLOW ADEQUATELY. THAT WAS AS MUCH INFORMATION THEY HAD AT HAND. THEY WOULD NEED TO GO BACK INTO CHARTS AND REVIEW GENDER AND AGES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23705781 ↗
• InjuryDec 3, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THERE HAD SINCE BEEN 3 MORE EVENTS WITH THE SIMILAR SITUATION WHERE THE FOLEY CATHETER WAS NOT DRAINED APPROPRIATELY. PATIENTS HAD BEEN BLADDER SCANNED AND FOUND TO HAVE URINE IN THEIR BLADDERS OR EXCHANGE OCCURS AND URINE FLOWS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23705776 ↗
• InjuryDec 2, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THERE HAD SINCE BEEN 3 MORE EVENTS WITH THE SIMILAR SITUATION WHERE THE FOLEY CATHETER WAS NOT DRAINED APPROPRIATELY. PATIENTS HAD BEEN BLADDER SCANNED AND FOUND TO HAVE URINE IN THEIR BLADDERS OR EXCHANGE OCCURS AND URINE FLOWS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23701284 ↗
• InjuryNov 24, 2025Complete Blockage; Component Misassembled; Complete Blockage; Component Misassembled

  IT WAS REPORTED THAT REPORTING NURSE HIT ROOM READY AT 0822. REPORTING NURSE WAS AT PRE OPERATING ROOM AT 0823. BLOCK WAS STILL BEING COMPLETED BY ANESTHESIA AT THAT TIME. BLOCK ENDED AT 0825 AND PATIENT WAS REPOSITIONED AND TESTED WITH ICE TO CHECK EPIDURAL. WHEN BLOCK ANESTHESIA DEPARTED FROM THE PRE OPERATING ROOM OPERATING ROOM NURSE CHECKED IN TO SEE WHEN IF EVERYONE WAS READY FOR PRE OPERATING HUDDLE. OPERATING ROOM NURSE WAS INFORMED THAT CLIPPING STILL NEEDED TO OCCUR. AT APPROXIMATELY 0831 OPERATING ROOM NURSE PROCEEDED INTO PRE OPERATING BAY TO ASK QUESTIONS OF THE PATIENT. BEFORE OPERATING ROOM NURSE ENTERED THE PRE OPERATING ROOM BAY, THE PATIENT WAS ASSIGNED PRE OPERATING ROOM NURSE TOLD ANOTHER PRE OPERATING NURSE THAT IT WAS VERIFIED HUDDLE BEFORE THEY PAGED SO THAT EVERYTHING WAS WRITTEN DOWN ON PRE-OP HUDDLE SHEET. AS ANESTHESIA RESIDENT AND OR NURSE WERE PRESENT IN PRE-OP BAY WITH PATIENT, PRE-OP HUDDLE WAS COMPLETED WITH A PRE-OP RN THAT WAS NOT ASSIGNED TO THE PATIENT. LAST VOID WAS NEITHER DISCLOSED ON THE SHEET, ABOUT, OR WRITTEN ON THE PRE-OP HUDDLE SHEET UNDER THE PRE-OP URINE COLUMN. PATIENT WAS TRANSPORTED BACK TO THE OR AND ENTERED AT 0840. PRE-INDUCTION

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23639980 ↗
• MalfunctionFeb 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY RECEIVED AN INCIDENT REPORT STATING THAT TWO OF THEIR BALLOONS OF TEMPORARY SENSING FOLEY CATHETER HAD BEEN FILLED WITH 10 MILLILITERS NORMAL SALINE, HOWEVER PATIENT WAS LEAKING URINE. WHEN THEY REMOVED THE FOLEY ONLY 7 MILLILITERS NORMAL SALINE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356767 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THEY RECEIVED AN INCIDENT REPORT STATING THAT TWO OF THEIR BALLOONS OF TEMPORARY SENSING FOLEY CATHETER HAD BEEN FILLED WITH 10 MILLILITERS NORMAL SALINE; HOWEVER, PATIENT WAS LEAKING URINE. WHEN THEY REMOVED THE FOLEY ONLY 7 MILLILITERS NORMAL SALINE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356765 ↗
• MalfunctionNov 27, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THEY HAD AN INCIDENT TODAY WITH A PATIENT. A BRAND-NEW TEMPERATURE SENSING FOLEY CATHETER WAS NOT INSERTED. IT WOULD NOT READ A TEMPERATURE AT ALL IMMEDIATELY AFTER INSERTION. THEIR BIOMED TEAM CAME TO THE BEDSIDE AND TESTED THE BROWN CABLE WHICH WAS WORKING. THEY ALSO BROUGHT A CABLE FROM THE BIOMED WORKSHOP THAT HAD BEEN READ ACCURATELY, BUT IT WOULD NOT PICK UP THE TEMPERATURE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795429 ↗
• MalfunctionNov 21, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THEY IDENTIFIED A PROBLEM WITH THE TEMPERATURE SENSING FOLEY CATHETER. THEY APPEARED TO BE LEAKING FROM THE INFLATION PORT. THEY IDENTIFIED A PROBLEM WITH THE TEMP EARLY ON IN THE CASE AND THEN NOTED THAT THERE WAS NO URINE DRAINING WHEN THEY INVESTIGATED, THEY SAW THAT THE FOLEY WAS OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749113 ↗
• MalfunctionSep 18, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DUE TO THE SILICONE LATEX SHORTAGE, CUSTOMER WERE NOW USING LATEX TEMPERATURE FOLEY CATHETER AND HAVING ISSUES WITH INACCURACY OF TEMPERATURE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08MAR2024, BOTH OF THESE PATIENTS WERE SEVERELY ILL AND ON ECMO. BIOMEDICAL ENGINEERING TESTED OUR CABLES WITH OUR SIMULATORS AND SAID THEY WERE WORKING PROPERLY. PROVIDED LOT NUMBERS WERE (LOT#NGHX3351, LOT#NGHX4795).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245349 ↗
• MalfunctionSep 18, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DUE TO THE SILICONE LATEX SHORTAGE, CUSTOMER WERE NOW USING LATEX TEMPERATURE FOLEY CATHETER AND HAVING ISSUES WITH INACCURACY OF TEMPERATURE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08MAR2024, BOTH OF THESE PATIENTS WERE SEVERELY ILL AND ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). BIOMEDICAL ENGINEERING TESTED OUR CABLES WITH OUR SIMULATORS AND SAID THEY WERE WORKING PROPERLY. PROVIDED LOT NUMBERS WERE (LOT#NGHX3351, LOT#NGHX4795).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245239 ↗
• MalfunctionMay 23, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHILE OPENING TEMPERATURE SENSING FOLEY TRAY FOR TRAINING ON SENSICA DEVICE AND NOTED THAT THE WHITE MARKING OF TEMPERATURE SENSING FOLEY CATHETER WAS AT THE WRONG END OF THE TUBING. IT APPEARS THE TUBING SHOULD HAVE BEEN FLIPPED. MARKING TOO CLOSE TO THE ACTUAL FOLEY, IT WOULD HAVE PROVIDED TOO MUCH SLACK. THEY WERE DOING TRAINING SESSION ON DEMO UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380859 ↗
• InjuryApr 26, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT ONCE INSERTED THE FOLEY CATHETER FAILED TO DRAIN THE BLADDER. BLADDER SCAN CONFIRMED URINE PRESENT, AND THEY REMOVED THE CATHETER AND FOUND THE PRODUCT TO BE DEFECTIVE. THEY WERE UNABLE TO FLUSH WATER THROUGH THE LUMEN OF THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6)2024, IT WAS REPORTED THAT THE CUSTOMER HAD ANOTHER FOLEY CATHETER THAT DID NOT WORK IN CARDIOVASCULAR OPERATING ROOM AND NEEDED TO BE REPLACED INTRAOPERATIVELY THAT DAY. IN EACH EVENT, THE TEMP-SENSING FOLEY CATHETER WAS INSERTED INTO THE BLADDER SUCCESSFULLY. NEITHER OF THESE FOLEY CATHETERS PRODUCED URINE RETURN. BLADDER SCANS POST INSERTION CONFIRMED URINE PRESENT IN THE BLADDER. THE FOLEYS WERE REMOVED IN EACH EVENT. THEY PLANNED TO LOOK AT THE LOT NUMBER OF THE AFFECTED PRODUCT AND PULLED ALL FOLEY KITS WITH SAME LOT NUMBER FROM INVENTORY TO BE SAFE. THEY WERE VERY CONCERNED THAT THEY MIGHT HAVE OTHER AFFECTED PRODUCT THROUGHOUT THE HOSPITAL THAT WAS PLACING THEIR PATIENT AT RISK. THIS WAS NOW A PATIENT SAFETY ISSUE AND WOULD LIKE SOME KIND OF FOLLOW UP FROM BD ALONG WITH CREDIT FOR ALL THE KITS THAT THEY WERE REMOVING FROM INVENTORY. PER CUSTOMER FOLLOW UP RECEIVED ON

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192934 ↗
• MalfunctionApr 25, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT ON TWO DIFFERENT OCCASIONS TEMPERATURE SENSING FOLEY CATHETER WOULD NOT DRAIN THE PATIENT'S BLADDER EVEN AFTER IRRIGATION. CUSTOMER ALSO STATED THEY HAD TROUBLE REMOVING THE FOLEY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183257 ↗
• MalfunctionApr 25, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT ON TWO DIFFERENT OCCASIONS TEMPERATURE SENSING FOLEY CATHETER WOULD NOT DRAIN THE PATIENT'S BLADDER EVEN AFTER IRRIGATION. CUSTOMER ALSO STATED THEY HAD TROUBLE REMOVING THE FOLEY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183251 ↗
• MalfunctionApr 25, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT ON TWO DIFFERENT OCCASIONS TEMPERATURE SENSING FOLEY CATHETER WOULD NOT DRAIN THE PATIENT'S BLADDER EVEN AFTER IRRIGATION (DOE# (B)(6) 2024 AND DOE# UNK). CUSTOMER ALSO STATED THEY HAD TROUBLE REMOVING THE FOLEY FROM THE PATIENT. PER FOLLOW UP VIA PHONE ON 25APR2024, IT WAS REPORTED THAT THE SAMPLE WAS THROWN AWAY. A NEW FOLEY WAS PLACED AND THE ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183250 ↗
• MalfunctionApr 15, 2024Inability to Irrigate; Component Misassembled; Inability to Irrigate; Component Misassembled

  IT WAS REPORTED THAT ONCE INSERTED THE FOLEY CATHETER FAILED TO DRAIN THE BLADDER. BLADDER SCAN CONFIRMED URINE PRESENT AND THEY REMOVED THE CATHETER AND FOUND THE PRODUCT TO BE DEFECTIVE. THEY WERE UNABLE TO FLUSH WATER THROUGH THE LUMEN OF THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08APR2024, IT WAS REPORTED THAT THE CUSTOMER HAD ANOTHER FOLEY CATHETER THAT DID NOT WORK IN CARDIOVASCULAR OPERATING ROOM (CVOR) AND NEEDED TO BE REPLACED INTRAOPERATIVELY THAT DAY. IN EACH EVENT, THE TEMPERATURE SENSING FOLEY CATHETER WAS INSERTED INTO THE BLADDER SUCCESSFULLY. NEITHER OF THESE FOLEY CATHETERS PRODUCED URINE RETURN. BLADDER SCANS POST INSERTION CONFIRMED URINE PRESENT IN THE BLADDER. THE FOLEYS WERE REMOVED IN EACH EVENT. THEY PLANNED TO LOOK AT THE LOT NUMBER OF THE AFFECTED PRODUCT AND PULLED ALL FOLEY KITS WITH SAME LOT NUMBER FROM INVENTORY TO BE SAFE. THEY WERE VERY CONCERNED THAT THEY MIGHT HAVE OTHER AFFECTED PRODUCT THROUGHOUT THE HOSPITAL THAT WAS PLACING THEIR PATIENT AT RISK. THIS WAS NOW A PATIENT SAFETY ISSUE AND WOULD LIKE SOME KIND OF FOLLOW UP FROM BD ALONG WITH CREDIT FOR ALL THE KITS THAT THEY WERE REMOVING FROM INVENTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111013 ↗
• InjuryApr 15, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT ONCE INSERTED THE FOLEY CATHETER FAILED TO DRAIN THE BLADDER. BLADDER SCAN CONFIRMED URINE PRESENT AND THEY REMOVED THE CATHETER AND FOUND THE PRODUCT TO BE DEFECTIVE. THEY WERE UNABLE TO FLUSH WATER THROUGH THE LUMEN OF THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08APR2024, IT WAS REPORTED THAT THE CUSTOMER HAD ANOTHER FOLEY CATHETER THAT DID NOT WORK IN CARDIOVASCULAR OPERATING ROOM (CVOR) AND NEEDED TO BE REPLACED INTRAOPERATIVELY THAT DAY. IN EACH EVENT, THE TEMPERATURE SENSING FOLEY CATHETER WAS INSERTED INTO THE BLADDER SUCCESSFULLY. NEITHER OF THESE FOLEY CATHETERS PRODUCED URINE RETURN. BLADDER SCANS POST INSERTION CONFIRMED URINE PRESENT IN THE BLADDER. THE FOLEYS WERE REMOVED IN EACH EVENT. THEY PLANNED TO LOOK AT THE LOT NUMBER OF THE AFFECTED PRODUCT AND PULLED ALL FOLEY KITS WITH SAME LOT NUMBER FROM INVENTORY TO BE SAFE. THEY WERE VERY CONCERNED THAT THEY MIGHT HAVE OTHER AFFECTED PRODUCT THROUGHOUT THE HOSPITAL THAT WAS PLACING THEIR PATIENT AT RISK. THIS WAS NOW A PATIENT SAFETY ISSUE AND WOULD LIKE SOME KIND OF FOLLOW UP FROM BD ALONG WITH CREDIT FOR ALL THE KITS THAT THEY WERE REMOVING FROM INVENTORY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104510 ↗
• MalfunctionFeb 15, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT ONE OF OUR TEMPERATURE SENSING FOLEY CATHETER WAS MISREADING AND THE TEMPERATURE WAS READING HIGH. STAFF ENDED UP UTILIZING OTHER MODALITIES AND THE PATIENT WAS AFEBRILE. SO, INDEED, THE FOLEY WAS READING HIGH IN COMPARISON TO ADDITIONAL MODALITIES THAT WERE UTILIZED. STAFF ENDED UP PULLING THE FOLEY. THERE WAS NO PATIENT HARM AND NO ADDITIONAL INTERVENTIONS OTHER THAN OBTAINING TEMPERATURE FROM OTHER MODALITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710687 ↗
• MalfunctionFeb 14, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THERE WAS MISREADING OF ONE OF TEMPERATURE-SENSING FOLEY CATHETER. THEY STATED TEMPERATURE WAS READING HIGH, STAFF ENDED UP UTILIZING OTHER MODALITIES AND THE PATIENT WAS AFEBRILE. SO, INDEED, THE FOLEY WAS READING HIGH IN COMPARISON TO ADDITIONAL MODALITIES THAT WERE UTILIZED. STAFF ENDED UP PULLING THE FOLEY BUT DID NOT KEEP THE PRODUCT TO SEND TO FIELD ASSURANCE. THERE WAS NO PATIENT HARM. NO ADDITIONAL INTERVENTIONS OTHER THAN OBTAINING TEMPERATURE FROM OTHER MODALITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703018 ↗