Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter 119314MRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741039904), received between Jun 13, 2018 and Nov 6, 2025 — classified as 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (17 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE FOLEY WITH A TEMPERATURE PROBE INDICATED TEMPERATURE 38.8 DEGREES C AT 0800 ON (B)(6) AND CONTINUED TO RISE REACHING UP TO 42.2 DEGREES C AT 1245. ESOPHAGEAL TEMPERATURE PROBE PLACED AT 1250 TO COMPARE READINGS, WHICH READ 33.7 DEGREES C. ESOPHAGEAL TEMPERATURE PROBE WAS CONFIRMED FOR PLACEMENT VIA CHEST X-RAY. THIS PATIENT WAS TREATED WITH ICE PACKS AND SCHEDULED TYLENOL AND LORAZEPAM 1 GM IV FOR PRESUMPTION OF PRESENCE OF SEIZURES WITH THE HIGH TEMPERATURE. THEY WERE ALSO DRAWN BLOOD CULTURES ON (B)(6) DUE TO TEMPERATURES ABOVE 38.3 DURING THAT DAY. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 12NOV2025, IT WAS REPORTED THAT THE CUSTOMER DOES NOT HAVE ANY PHYSICAL SAMPLES, OR LOT/SERIAL NUMBERS. CUSTOMER WAS UNSURE OF WHAT KIND OF TROUBLESHOOTING COULD BE PERFORMED ON THIS DEVICE. ADDITIONALLY, ONCE THE CATHETER WAS PLACED IT WAS NOT OUR PRACTICE TO SAVE THE PACKAGING. CUSTOMER DO HAVE PATIENT INFORMATION, BUT THEY WERE UNSURE WHAT WAS HOSPITAL POLICY ON PROVIDING THE DETAILS TO INDIVIDUALS OUTSIDE OF ORGANIZATION FOR THIS TYPE OF SITUATION. THE REPORT THAT CUSTOMER HAVE ABOUT THE PATIENT WAS ALMOST WORD-FOR-WORD THE SAME INFORMATION THAT WAS GIVEN ALR

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

  MAUDE report 23488461 ↗
• MalfunctionOct 3, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THERMISTOR FOLEY INSERTED INTO PATIENT AND READ 39.5 ON BLANKETROL COOLING SYSTEM AS WELL AS BEDSIDE MONITOR. COOLING INITIATED FOR WITH CORE TEMPERATURE GOAL TO BE 38. AFTER ONE HOUR, PATIENT NOTED TO HAVE INCREASED VENTRICULAR ECTOPY AND WAS COOL TO TOUCH. TEMPERATURE NOTED TO BE 39.1 ON BLANKETROL COOLING MACHINE AS WELL AS VIA CABLE TO READ FROM PHILIPS BEDSIDE MONITOR. TEMPORAL TEMPERATURE NOTED TO BE 35.6. THERMISTOR FOLEY CATHETER REPLACED WITH TEMPERATURE READING 38.0 ON BOTH MONITORS, WITH THE FIRST THERMISTOR FOLEY READING 39.1, A NOTED TEMPERATURE DIFFERENCE. HOSPITAL USER STATED INACCURATE READING OF THERMISTOR FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23210915 ↗
• MalfunctionAug 26, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERMOSTER CATHETER STOPPED READING TEMPERATURE. PATIENT HAD BEEN FEBRILE AND HAVING ACCURATE TEMPERATURE MONITORING WAS IMPORTANT. ATTEMPTED TO TROUBLESHOOT BY DISCONNECTING AND RECONNECTING AT BOTH THE CABLE-CATHETER CONNECTION AS WELL AS THE CABLE TO TRAM CONNECTION WITH NO RESULT AND THEN SWITCHED THE CABLE OUT COMPLETELY WITH NO EFFECT EITHER. THE ENTIRE CATHETER HAD TO BE REPLACED IN ORDER TO CONTINUE TEMPERATURE MONITORING WHICH MEANT AN UNNECESSARY INVASIVE PROCEDURE FOR THE PATIENT. NO PATIENT HARM WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16SEP2025, IT WAS REPORTED THAT NO SERIOUS HARM WAS REPORTED. UNFORTUNATELY, THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894745 ↗
• MalfunctionAug 1, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS SLOWLY LEAKING WHICH LED TO THE FOLEY FALLING OUT.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686674 ↗
• MalfunctionJun 27, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER HAD TO RETURN 41 EACH OF FOLEY TRAY THAT HAVE AN ONGOING FIELD ASSURANCE CASE. THEY FELT THAT THE PRODUCT MIGHT HAVE ALL BEEN IMPACTED AND DID NOT WANT TO USE THE FOLEYS. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 20JUN2025, IT APPEARED THE BALLOON WAS DEFLATING, AND THE CATHETER WAS FALLING OUT, ON THIS EMAIL SAID THERE WAS A PIN SIZED HOLE IN THE TUBING CAUSED A SLOW LEAK; THEY HAVE THE DEFECTIVE ITEM IN A HAZARD BAG TO SHIP TO YOUR QUALITY DEPARTMENT FOR INVESTIGATION. THIS WAS THE THIRD TIME IT HAPPENED HERE. IT WAS NOTED THAT THE GIVEN LOTS # WERE NGJX3255, NGJU4341, NGJV3644.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346421 ↗
• MalfunctionJun 27, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER HAD TO RETURN 41 EACHES OF FOLEY TRAY THAT HAVE AN ONGOING FIELD ASSURANCE CASE. THEY FELT THAT THE PRODUCT MIGHT HAVE ALL BEEN IMPACTED AND DID NOT WANT TO USE THE FOLEYS. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 20JUN2025, IT APPEARED THE BALLOON WAS DEFLATING, AND THE CATHETER WAS FALLING OUT, ON THIS EMAIL SAID THERE WAS A PIN SIZED HOLE IN THE TUBING CAUSED A SLOW LEAK; THEY HAVE THE DEFECTIVE ITEM IN A HAZARD BAG TO SHIP TO YOUR QUALITY DEPARTMENT FOR INVESTIGATION. THIS WAS THE THIRD TIME IT HAPPENED HERE. IT WAS NOTED THAT THE GIVEN LOTS# WERE NGJX3255, NGJU4341, NGJV3644.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346411 ↗
• MalfunctionJun 27, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER HAD TO RETURN 41 EACHES OF FOLEY TRAY THAT HAVE AN ONGOING FIELD ASSURANCE CASE. THEY FELT THAT THE PRODUCT MIGHT HAVE ALL BEEN IMPACTED AND DID NOT WANT TO USE THE FOLEYS. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 20JUN2025, IT APPEARED THE BALLOON WAS DEFLATING, AND THE CATHETER WAS FALLING OUT, ON THIS EMAIL SAID THERE WAS A PIN SIZED HOLE IN THE TUBING CAUSED A SLOW LEAK; THEY HAVE THE DEFECTIVE ITEM IN A HAZARD BAG TO SHIP TO YOUR QUALITY DEPARTMENT FOR INVESTIGATION. THIS WAS THE THIRD TIME IT HAPPENED HERE. IT WAS NOTED THAT THE GIVEN LOTS# WERE NGJX3255, NGJU4341, NGJV3644.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346385 ↗
• MalfunctionJun 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BALLOON ON FOUR DIFFERENT FOLEYS CATHETERS DEFLATED AND FELL OUT OF THE PATIENT. (LOT#NGJQ1070 AND LOT#NGJR1840)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211596 ↗
• MalfunctionJun 2, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER WAS REMOVED FROM PATIENT IN MEDICAL INTENSIVE CARE UNIT RM 4. THE BALLOON DID NOT DEFLATE COMPLETELY WHEN ASPIRATED THE FLUID. THEY PULLED THE CATHETER FROM THE PATIENT, AND IT CAUSED THEM SOME DISCOMFORT. WHEN IT CAME OUT, THEY CHECKED THE CATHETER, AND IT LOOKED LIKE THE PICTURE BELOW WHEN IT CAME OUT. IT SLOWLY DEFLATED AFTER MAYBE 1 TO 2 MINUTES. INFUSED SOME WATER AGAIN TO SEE IF IT WOULD INFLATE AND IT DID, HOWEVER IT WOULD NOT DEFLATE EVEN WITH STRONG PULL FROM THE SYRINGE PLUNGER. THEY PLACED THE FOLEY IN RED BIO-HAZARD BAG AND PLACED IT ON TOP OF THE SUPPLY CART. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 22124676 ↗
• MalfunctionMay 14, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THE NOTED RAPID TEMPERATURE CHANGE ON THERMISTOR, PATIENT TEMPERATURE HAD BEEN 38 DEGREES ALL SHIFT, AND WRITER NOTED TEMPERATURE DROPPING DOWN TO 36 DEGREES. WRITER WALKED INTO ROOM, AND LIFTED FOLEY CATHETER, NOTED THAT IT WAS NO LONGER IN PATIENT, AND THAT FOLEY BALLOON WAS NOT INFLATED. WRITER THEN ATTEMPTED TO INJECT 10CC OF NORMAL SALINE TO CONFIRM IF BALLOON WAS INTACT. NOTED FLUID COMING OUT OF BALLOON, WHEN ATTEMPTING TO INFLATE. WRITER ASSUMED THAT THE BALLOON HAD SPONTANEOUSLY RUPTURED, BASED ON FACT THAT WITH PREVIOUS TURNS ON CURRENT SHIFT, AND PRIOR SHIFT THAT THE FOLEY HAD NOT DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019817 ↗
• MalfunctionFeb 20, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THIS WAS THE ITEM FOR FLINT. THEY WERE GETTING SAFETY FIRSTS EVERY DAY ABOUT THIS DEFECTIVE KIT. THERE WAS SMALL HOLE AT TOP OF TEMP CATHETER, BALLOON DEFLATING, URINE FLOWING OUT AFTER MOVING THE TUBING, FOLEY CATHETER NOT DRAINING PROPERLY WITH NO KINKS IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424087 ↗
• MalfunctionFeb 20, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THIS WAS THE ITEM FOR FLINT. THEY WERE GETTING SAFETY FIRSTS EVERY DAY ABOUT THIS DEFECTIVE KIT. THERE WAS SMALL HOLE AT TOP OF TEMP CATHETER, BALLOON DEFLATING, URINE FLOWING OUT AFTER MOVING THE TUBING, FOLEY CATHETER NOT DRAINING PROPERLY WITH NO KINKS IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424085 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT WRITER WAS INSERTING A TEMPERATURE SENSING FOLEY CATHETER (SURESTEP FOLEY TRAY SYSTEM BY BARD MEDICAL - REF: (B)(4) FOR A NEWLY ADMITTED PATIENT IN INTENSIVE CARE UNIT. ONCE INSERTED, WRITER INJECTED 10CC OF PROVIDED NORMAL SALINE INTO BALLOON PORT AS PER PROTOCOL. WRITER IMMEDIATELY NOTICED THAT WATER WAS LEAKING OUT OF THE TOP OF THE "Y" SITE (THE PART WHERE THE TEMPERATURE CABLE, FOLEY ITSELF AND INJECTION PORT FOR BALLOON INFLATION MEET). THE WATER CONTINUED TO BUBBLE OUT OF THIS AREA. BALLOON WAS THEN DEFLATED, FOLEY REMOVED AND A BRAND NEW ONE WAS INSERTED WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404697 ↗
• MalfunctionFeb 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A SMALL HOLE AT TOP OF TEMPERATURE SENSING FOLEY CATHETER AND BALLOON DEFLATING, URINE FLOWING OUT AFTER MOVING THE TUBING AND FOLEY CATHETER NOT DRAINING PROPERLY WITH NO KINKS IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401606 ↗
• MalfunctionFeb 18, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS VERY POSITIONAL. FOLEY SHOULD BE DRAINING APPROPRIATELY BUT TO GET URINE TO DRAIN THEY HAD TO LIFT UP THE TUBING ABOVE THE BLADDER AND THEN LOWER IT AND DID THIS MORE THAN 6 TIMES TO GET 25ML OF URINE INSTEAD OF ONLY THE 30 ML THAT DRAINED INITIALLY. TUBING HAD TO BE MANIPULATED EVERY HOUR TO GET ACCURATE I/OS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399519 ↗
• MalfunctionFeb 14, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON WAS DEFLATING, AND THE CATHETER WAS FALLING OUT, ON THIS EMAIL SAID THAT THERE WAS A PIN SIZED HOLE IN THE TUBING CAUSING A SLOW LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384106 ↗
• MalfunctionFeb 14, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BALLOON APPEARS TO BE DEFLATED, AND THE TEMPERATURE SENSING FOLEY CATHETER WAS FALLING OUT, THERE WAS A PIN SIZED HOLE IN THE TUBING CAUSING A SLOW LEAK. THIS WAS THE THIRD TIME IT HAD HAPPENED HERE. THIS WAS INSTALLED IN THE PATIENT IN THE OPERATING ROOM, SO THE FOLEY CAME FROM THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21383727 ↗
• MalfunctionFeb 11, 2025Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT PATIENT HAD A HISTORY OF ABDOMINAL HYPERTENSION DURING THIS ADMISSION. ORDER TO OBTAIN Q4H INTRA-ABDOMINAL BLADDER PRESSURES. WRITER LAID PATIENT SUPINE AND FLAT PER POLICY, CLAMPED TEMPERATURE SENSING FOLEY CATHETER DISTAL TO INJECTION PORT, ATTACHED PRESSURE MONITORING DEVICE, PRIMED 50CC SYRINGE WITH 25CC OF NORMAL SALINE AND THEN ATTEMPTED TO FLUSH FOLEY. FOLEY WAS FLUSHED WITH DIFFICULTY. BLADDER PRESSURES READ 250. UNCLAMPED FOLEY TO LET FLUSH FLUID DRAIN AND ATTEMPTED PROCESS AGAIN WITH SAME RESULT. DISCONNECTED CATHETER FROM FOLEY BAG AND FLUSHED AND ASPIRATED FOLEY DIRECTLY AT CATHETER WITH 50CC OF NORMAL SALINE WITH EASE. CLAMPED TUBING DISTAL TO INJECTION PORT AND ATTEMPTED TO FLUSH TUBING WHILE NOT CONNECTED TO CATHETER AND AGAIN WAS MET WITH DIFFICULTY. ATTEMPTED TO DISCONNECTED AND RECONNECT FROM FLUSH PORT 3 TIMES WITH THE SAME LEVEL OF RESISTANCE MET. THEY REPLACED TUBING WITH NEW TUBING OR UROMETER AND RETAINED OLD TUBING OR UROMETER. AS THIS PATIENT HAD PREVIOUSLY HIGH BLADDER PRESSURES, THIS POSED A POTENTIAL HARM TO PATIENT AS THE BLADDER PRESSURES WERE DEEMED NOT TO BE ACCURATE AND A POTENTIAL HIGH BLADDER PRESSURE EVENT COULD HAVE BEEN MIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356757 ↗
• MalfunctionDec 10, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER HAD INSERTED THERMISTER FOLEY CATHETER AS PER PROTOCOL TO THE PATIENT. BALLOON WAS INFLATED WITH 10 CC OF STERILE WATER AND URINE RETURNED AS PER INSERTION. UPON CHECKING ON THE URINE OUTPUT 1 HOUR LATER THERE WAS NO URINE NOTED. WHEN WRITER WENT TO TROUBLESHOOT THE OUTPUT, THE FOLEY FELL OUT AND THE BALLOON HAD BEEN DEFLATED. BALLOON APPEARED TO HAVE PASSIVELY DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891922 ↗
• MalfunctionNov 20, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN INSERTED A TEMPERATURE SENSING FOLEY CATHETER AND TRIED TO INFLATE, THERE WAS A SMALL HOLE IN THE CATHETER CAUSING THE SALINE TO SQUIRT OUT, AND IT COULD NOT BE INFLATED. THE CUSTOMER HAD TO REMOVE THE CATHETER AND INSERT A NEW ONE. THEY DID NOT HAVE ANY TEMPERATURE FOLEYS ON THE UNIT SO THE PATIENT WAS PUT IN A REGULAR FOLEY CATHETER. THE PATIENT HAD TO GET TWO FOLEYS AND NOTICED SOME BLOOD IN THE URINE AFTER INSERTION OF THE SECOND CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hematuria

  MAUDE report 20732674 ↗
• InjurySep 20, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT ON FRIDAY (B)(6)2024, A DH NURSE PLACED A 14FR FOLEY CATHETER ON A PATIENT AND THERE WAS A MALFUNCTION OF THE BALLOON. THE UROLOGIST WAS CALLED IN TO REMOVE THE CATHETER BECAUSE THE BALLOON WOULD NOT INFLATE AND THE REGISTERED NURSE WAS UNABLE TO REMOVE THE 2MLS OF FLUID THEY HAD PUT INTO THE BALLOON. WHEN THE UROLOGIST CAME IN, THEY HAD TO USE A GUIDE WIRE TO PUNCTURE THE BALLOON TO INFLATE IT AND REMOVE THE CATHETER. PER FOLLOW UP VIA EMAIL ON 10SEP2024, IT WAS REPORTED THAT 14FR FOLEY CATHETER PLACED FOR VCUG UNDER SEDATION WAS PLACED IN THE URETHRA AND THE BALLOON WAS INFLATED WITH 2ML OF FLUID. THE CATHETER WAS NOT ABLE TO BE PULLED BACK INTO PROPER POSITION AND THE FLUID IN THE BALLOON WAS UNABLE TO BE REMOVED. THE TEAM TROUBLESHOOTED THE CATHETER REMOVAL AND WERE UNABLE TO REMOVE THE CATHETER. THE UROLOGIST WAS CALLED EMERGENTLY TO ASSIST WITH CATHETER REMOVAL. THE CATHETER PORT WAS CUT DURING THE TROUBLESHOOTING PROCESS SO WHEN THE UROLOGIST ARRIVED, THEY PLACED A SENSOR WIRE VIA THE CUT BALLOON PORT AND WAS ABLE TO DISLODGE FLUID FROM THE BALLOON. AT THAT POINT, THE CATHETER WAS REMOVED. THE PATIENT WAS RE-PREPPED AND ANOTHER CATHETER WAS PLACED WITH S

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

  MAUDE report 20266073 ↗
• MalfunctionSep 13, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS NO LONGER READING TEMPERATURE DESPITE ONLY BEING INSITU 48HRS. ATTEMPTED TROUBLESHOOTING STRATEGIES WITHOUT SUCCESS. EXCHANGED CATHETER FOR NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211697 ↗
• MalfunctionAug 2, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT TEMPERATURE SENSING FOLEY CATHETER THERMISTOR NOT REGISTERED APPROPRIATE CORE TEMPERATURE ON PATIENT. AS A RESULT, HAD TO RELY ON NON-CORE TEMPERATURE FOR TREATMENTS. NO APPARENT HARM BUT INCONVENIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 19892127 ↗
• MalfunctionJun 17, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT DEFLATE WHEN IT WAS CHECKED BEFORE INSERTION BY A LABOR AND DELIVERY NURSE. DEVICE WAS SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546971 ↗
• MalfunctionMay 2, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE NURSE HAD TO CHANGE THE FOLEY CATHETER OUT DUE TO LEAKING. THEY SAVED THE CATHETER, AND WHEN THEY TESTED IT, THE BALLOON EXPANDED WITH THE 10 ML OF SALINE BUT THEN AFTER 5 MINUTES HAD COMPLETED DEFLATED FROM A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228538 ↗