Bardex® I.C. Foley Catheter 0165SI24Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00801741016790), received between Apr 16, 2018 and Nov 26, 2025 — classified as 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (13 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT DEFLATE. CUSTOMER HAD TO GO THE UROLOGIST FOR ASSISTANCE.

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

  MAUDE report 23658295 ↗
• MalfunctionAug 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT STATES THE FOLEY IS SPLIT OPEN AND WAS NOT SEALED. WE HAVE REPLACED PRODUCT FOR THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913953 ↗
• MalfunctionAug 23, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NATURALLY REMOVED IMMEDIATELY AFTER PLACEMENT WHEN THEY INFLATED THE BALLOON AGAIN STERILE WATER LEAKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050594 ↗
• MalfunctionApr 15, 2024Dent in Material; Dent in Material

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON NOT INFLATED EVENLY PRIOR TO INSERTION, AND THIS CREATED LEAKAGE. THIS OCCURRED FREQUENTLY AND CHANGED THEM EVERY 5 DAYS WHEN PRIOR TO THIS ISSUE THEY HAD CHANGED THEM OUT EVERY 2 WEEKS. PATIENT SAW THEIR UROLOGIST IN FEBRUARY FOR ANNUAL EXAM. DOCTOR COULD OFFER NO EXPLANATION ANATOMICALLY NO CHANGES WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106199 ↗
• MalfunctionJun 23, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT FOLEY CATHETER STOPPED WORKING AFTER 7 DAYS TUBE CANNOT FLUSH. PER FOLLOW UP VIA EMAIL ON 12JUN2023, THE CUSTOMER STATED THAT THEY WERE STABLE FOR NOW, BUT VERY CONCERNED ABOUT SEVERAL CATHETERS NOT WORKING PROPERLY. THIS WAS NOT THE ONLY ONE TO FAIL. SEVERAL FAILED THIS YEAR, AND SINCE THEIR INSURANCE WILL ONLY PAY FOR ONE A MONTH, SEVERAL WERE PAID OUT OF POCKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192113 ↗
• MalfunctionSep 20, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER STOPPED WORKING AFTER ABOUT A WEEK OF USE. CUSTOMER STATED THAT IT TAKES ABOUT A WEEK UNTIL ADVERSE SYMPTOMS SHOW AND POSSIBLE URINARY TRACT INFECTION WITHOUT CATHETER. CUSTOMER STATED THAT THERE WAS NO SYMPTOMS FOR NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454864 ↗
• InjuryJul 18, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT IN THE END OF 2021 AND ON (B)(6) 2022 THE CUSTOMER ASSIGNED A CASE # (B)(4). THE PROBLEM REMAINED TO BE RESOLVED AND HAD REACHED A LEVEL OF URGENCY, AND ALL OUR SUPRAPUBIC CATHETER TUBE MODELS WERE ISOLATED AS 18 BARDEX MODELS THAT COULD BE AN IMPROVEMENT. PER FOLLOW-UP VIA EMAIL ON 05JUL2022, THE CUSTOMER STATED THAT IT WAS NOT A COMPLAINT, AND THEY WERE USING BARDEX AG, AND IT GOT PLUGGED UP EVERY FIVE DAYS. THE PATIENT WAS CURRENTLY IN THE HOSPITAL WITH A 3 CM CALCULUS IN THE BLADDER. THEY WANTED TO RUN A STUDY AND TEST, OUT OF OUR 35 MODELS THAT WE MAKE, THE 18 MODELS THAT, ACCORDING TO THE DESCRIPTIONS, IT MIGHT NOT GET PLUGGED AS READILY. THE CUSTOMER CONTACTED BD TECHNICAL DEPARTMENT AND THE TECHNICAL DEPARTMENT SAID THAT THIS WAS A PROBLEM THEY CONSTANTLY RUN INTO WITH OTHER CUSTOMERS. CUSTOMER WANTED 2 OR 3 SAMPLES OF EACH OF THE 18 BARDEX MODELS OF 24FR SIZE LISTED THAT MAY HELP KEEP THE SP TUBE UNPLUGGED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW-UP VIA EMAIL ON 08JUL2022, CUSTOMER WERE USING BARDEX I.C. ANTI-INFECTIVE FOLEY CATHETER. BY THE WAY, THEY POINTED OUT TO EVERYONE THAT THE PRODUCT SAID 5CC, BUT THEY USED A 10CC AND

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 15040133 ↗
• MalfunctionMay 31, 2022Decrease in Pressure; Failure to Infuse; Decrease in Pressure; Failure to Infuse

  IT WAS REPORTED THAT THE DISTILLED WATER COULD NOT BE INJECTED INTO THE FOLEY CATHETER AFTER PLACEMENT AND UNABLE TO PUSH PLUNGER AT ALL. IT WAS NOTED THAT PRETEST WAS DONE. THE WATER WAS INJECTED GENTLY, AND THE INFLATION FUNNEL WAS NOT SWELLED. IT WAS STATED THAT THE BALLOON CAN BE INFLATED WITHIN AROUND 10 SECONDS. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2022, IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550046 ↗
• MalfunctionDec 14, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING. PATIENT THOUGHT THAT THE BALLOON WAS BLOCKING THE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003398 ↗
• MalfunctionDec 5, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT ALLOWING THE FLUID TO PASS, AS IF THE EYELET WAS CLOGGED. THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS. IT WAS MENTIONED AS AN OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931278 ↗
• MalfunctionOct 6, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE TWO OF THE FOLEY CATHETERS STOPPED DRAINING. ALSO STATED THAT THE PATIENT HAD TWO DEFECTIVE FOLEY CATHETERS AND USED TWO INSERTION TRAYS TO INSERT THE DEFECTIVE FOLEY¿S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12582973 ↗
• MalfunctionJun 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE 24 FR BARDEX IC FOLEY CATHETER HAD NOT DRAINED FOR ABOUT 2 WEEKS AFTER BEING CHANGED. THE USER HAD TO CUT THE TIP OFF AND INFLATED BALLOON OF THE CATHETER BUT THERE WAS NO OBSTRUCTION FOUND. CUSTOMER STATED THAT ONE OR TWO HAPPENED USING THE CATHETER AND TWO MORE WERE REPORTED IN PATIENTS HOME CHANGES, WHERE ONE WAS WITH LOT NUMBER NGEX487 AND FOR THE OTHER THEY DID NOT HAVE THE LOT NUMBER. THE USER DID FEW SLEUTHING LIKE CUTTING THE TIP OFF AND INFLATED BALLOON OF THE 2-WEEK-OLD CATHETER WHERE THE BALLOON MATERIAL HAD OCCLUDED THE INNER LUMEN OF THE CATHETER AND NO LONGER WAS DRAINING. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 02APR21, CUSTOMER STATED THAT AT LEAST 7 PATIENTS HAD SIMILAR ISSUES AND ALL THE PATIENTS HAD BEEN USING THE 24 FR BARDEX IC FOLEY CATHETERS. STATED THAT THE FOLEY CATHETER QUIT DRAINING. WHEN THE USER ATTEMPTED TO IRRIGATE, THEY COULD GET WATER TO FLUSH IN, BUT THEY COULD NOT GET ANY TO DRAIN BACK OUT. THE CATHETER DRAINED FINE ONLY WHEN THEY DEFLATED THE BALLOON FOR EXCHANGE. THIS HAD HAPPENED WITH PATIENTS GETTING EXCHANGED IN THEIR HOME AS WELL AS FOR PATIENTS GETTING EXCHANGED IN THE CLINICS. MOST OF THE TIME, PATIENTS WE

  Patient problems: Chest Pain

  MAUDE report 12003129 ↗
• MalfunctionApr 21, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING ABOUT 2 WEEKS AFTER BEING CHANGED. THE USER HAD DONE FEW SLEUTHING LIKE CUTTING THE TIP OFF AND INFLATED BALLOON OF THE 2 WEEK OLD CATHETER, WHERE IT SHOWED THE BALLOON MATERIAL HAD OCCLUDED THE INNER LUMEN OF THE CATHETER AND IT WAS NOT DRAINING. PER ADDITIONAL INFORMATION RECEIVED, AT LEAST 7 PATIENTS HAD SIMILAR ISSUES, WHERE THE FOLEY CATHETER QUIT DRAINING. WHEN THE USER ATTEMPTED TO IRRIGATE, THEY COULD GET WATER TO FLUSH IN, BUT THEY COULD NOT GET ANY TO DRAIN BACK OUT. SOME HAD THE SAME ISSUE AND WHEN THEY DEFLATE THE BALLOON OR EXCHANGE THE CATHETER, IT DRAINED. MOST OF THE TIME PATIENTS WERE NOTICING THE ISSUE ABOUT 2-3 WEEKS AFTER THE EXCHANGE. ALSO STATED THAT WHEN A CATHETER WAS PULLED OUT OF A PATIENT AFTER ABOUT 2 WEEKS AND RE-INFLATED THE BALLOON, IT CLEARLY SHOWED THE BLOCKING IN LUMEN OF THE CATHETER. PER FOLLOW UP VIA EMAIL ON 14APR2021, CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH 24 FR CATHETERS WITH VARIOUS LOTS. EACH CASE HAPPENED AT ALMOST EXACTLY 2 WEEKS AFTER THE CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701651 ↗
• MalfunctionApr 20, 2021Partial Blockage; Inaccurate Flow Rate; Partial Blockage; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING ABOUT 2 WEEKS AFTER BEING CHANGED. THE USER HAD DONE FEW SLEUTHING LIKE CUTTING THE TIP OFF AND INFLATED BALLOON OF THE 2-WEEK-OLD CATHETER, WHERE IT SHOWED THE BALLOON MATERIAL HAD OCCLUDED THE INNER LUMEN OF THE CATHETER AND IT WAS NOT DRAINING. PER ADDITIONAL INFORMATION RECEIVED, AT LEAST 7 PATIENTS HAD SIMILAR ISSUES, WHERE THE FOLEY CATHETER QUIT DRAINING. WHEN THE USER ATTEMPTED TO IRRIGATE, THEY COULD GET WATER TO FLUSH IN, BUT THEY COULD NOT GET ANY TO DRAIN BACK OUT. SOME HAD THE SAME ISSUE AND WHEN THEY DEFLATE THE BALLOON OR EXCHANGE THE CATHETER, IT DRAINED. MOST OF THE TIME PATIENTS WERE NOTICING THE ISSUE ABOUT 2-3 WEEKS AFTER THE EXCHANGE. IT WAS ALSO STATED THAT WHEN A CATHETER WAS PULLED OUT OF A PATIENT AFTER ABOUT 2 WEEKS AND RE-INFLATED THE BALLOON, IT CLEARLY SHOWED THE BLOCKING IN LUMEN OF THE CATHETER. PER FOLLOW UP VIA EMAIL ON (B)(6) 2021, CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH 24 FR CATHETERS WITH VARIOUS LOTS. EACH CASE HAPPENED AT ALMOST EXACTLY 2 WEEKS AFTER THE CATHETER WAS INSERTED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, CUSTOMER HAD ANOTHER DEFECTIVE FOLEY ON (B)(6) 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697177 ↗
• MalfunctionApr 20, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING ABOUT 2 WEEKS AFTER BEING CHANGED. THE USER HAD DONE FEW SLEUTHING LIKE CUTTING THE TIP OFF AND INFLATED BALLOON OF THE 2 WEEK OLD CATHETER, WHERE IT SHOWED THE BALLOON MATERIAL HAD OCCLUDED THE INNER LUMEN OF THE CATHETER AND IT WAS NOT DRAINING. PER ADDITIONAL INFORMATION RECEIVED, AT LEAST 7 PATIENTS HAD SIMILAR ISSUES, WHERE THE FOLEY CATHETER QUIT DRAINING. WHEN THE USER ATTEMPTED TO IRRIGATE, THEY COULD GET WATER TO FLUSH IN, BUT THEY COULD NOT GET ANY TO DRAIN BACK OUT. SOME HAD THE SAME ISSUE AND WHEN THEY DEFLATE THE BALLOON OR EXCHANGE THE CATHETER, IT DRAINED. MOST OF THE TIME PATIENTS WERE NOTICING THE ISSUE ABOUT 2-3 WEEKS AFTER THE EXCHANGE. ALSO STATED THAT WHEN A CATHETER WAS PULLED OUT OF A PATIENT AFTER ABOUT 2 WEEKS AND RE-INFLATED THE BALLOON, IT CLEARLY SHOWED THE BLOCKING IN LUMEN OF THE CATHETER. PER FOLLOW UP VIA EMAIL ON 14APR2021, CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH 24 FR CATHETERS WITH VARIOUS LOTS. EACH CASE HAPPENED AT ALMOST EXACTLY 2 WEEKS AFTER THE CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697108 ↗
• MalfunctionMar 26, 2021Inaccurate Flow Rate; Insufficient Device Problem Information; Inaccurate Flow Rate; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TWO OF THE THREE FOLEY CATHETERS RECEIVED BY THE PATIENT WERE BAD AND DID NOT WORK. NO SPECIFICS WERE GIVEN. PER ATTACHMENT VIA EMAIL ON 12MAR2021, FOLEY CATHETERS WAS NOT DRAINING THE URINE FROM THE BLADDER. PER FOLLOW UP VIA PHONE 13APR2021, THE CATHETER STOPPED DRAINING AFTER 2 OR 3 DAYS OF USE. CUSTOMER NOTED THAT THIS RESULTED IN URINE LEAKING FROM THE STOMA AND CAUSED THE PATIENT¿S BLOOD PRESSURE TO RISE. NO MEDICAL INTERVENTION WAS REQUIRED, ONCE THE CATHETER WAS REPLACED, THE BLOOD PRESSURE WENT BACK TO NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576520 ↗
• MalfunctionJan 3, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND FOLEY CATHETER WITH A 5CC BALLOON LEAKED FROM THE SITE (SUPRAPUBIC CATHETER). SO THE PATIENT DECIDED TO FILL UP THE FOLEY BALLOON OUTSIDE THE BODY AND STATED THAT THE BALLOON WAS ASYMMETRICAL. NO MEDICAL INTERVENTION REPORTED. PER MSS RESPONSE, THE FOLEY BALLOON WAS ONLY FILLED WITH 5CC OF STERILE WATER INSTEAD OF 10CC. SO THE PATIENT WAS INFORMED OF THE CORRECT AMOUNT AND HOW NOT FILLING TO THE AMOUNT MIGHT LEAD TO AN ASYMMETRICAL BALLOON. PER FOLLOW UP ON 09DEC2020, THE CUSTOMER NOTED THAT THE CATHETERS WERE BEING INFLATED WITH THE FULL 10CC AND NOT 5CC AS INITIALLY STATED. ALSO, THE CATHETER WAS NOT DRAINED WHILE IN PLACE WHICH CAUSED LEAKAGE , SO THE CUSTOMER REMOVED THE CATHETER AND INFLATED. UPON INFLATION, THE PATIENT NOTICED THAT THE BALLOON WAS INFLATING ASYMMETRICALLY.

  Patient problems: Pain

  MAUDE report 11105597 ↗
• MalfunctionDec 30, 2020Dent in Material; Dent in Material

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND FOLEY CATHETER WITH A 5CC BALLOON LEAKED FROM THE SITE (SUPRAPUBIC CATHETER). SO THE PATIENT DECIDED TO FILL UP THE FOLEY BALLOON OUTSIDE THE BODY AND STATED THAT THE BALLOON WAS ASYMMETRICAL. NO MEDICAL INTERVENTION REPORTED. PER MSS RESPONSE, THE FOLEY BALLOON WAS ONLY FILLED WITH 5CC OF STERILE WATER INSTEAD OF 10CC. SO THE PATIENT WAS INFORMED OF THE CORRECT AMOUNT AND HOW NOT FILLING TO THE AMOUNT MIGHT LEAD TO AN ASYMMETRICAL BALLOON. PER FOLLOW UP ON 09DEC2020, THE CUSTOMER NOTED THAT THE CATHETERS WERE BEING INFLATED WITH THE FULL 10CC AND NOT 5CC AS INITIALLY STATED. ALSO, THE CATHETER WAS NOT DRAINED WHILE IN PLACE WHICH CAUSED LEAKAGE, SO THE CUSTOMER REMOVED THE CATHETER AND INFLATED. UPON INFLATION, THE PATIENT NOTICED THAT THE BALLOON WAS INFLATING ASYMMETRICALLY.

  Patient problems: Pain

  MAUDE report 11097785 ↗
• MalfunctionDec 3, 2020Fluid/Blood Leak; Decrease in Pressure; Fluid/Blood Leak; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER BALLOON INFLATED TO 10 CC. WHEN THE USER DEFLATED THE BALLOON TO REMOVE THE LEAKING CATHETER ONLY 5 CC WAS IN THE SYRINGE AND THE BALLOON WAS COMPLETELY DEFLATED. THE FOLEY SLIDE OUT AND REPLACED. MS AND S RESPONDED THAT THE FOLEY CATHETER BALLOON COULD LOSE WATER VIA OSMOSIS ESPECIALLY IN CONCENTRATED URINE. PER FOLLOW UP VIA PHONE ON 10NOV2020 THE BALLOON DEFLATED ON ITS OWN AFTER A COUPLE OF DAYS OF USE. THE WATER WAS LOST FROM THE BALLOON WHICH INDICATED CATHETER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10939146 ↗
• InjuryMay 21, 2020Inaccurate Flow Rate; Inaccurate Flow Rate; Defective Component; No Flow

  IT WAS REPORTED, THAT THE PATIENT HAS BEEN HOSPITALIZED FOUR TIMES. FOR URINARY INFECTION, WHILE USING THE 2 WAY 5CC FOLEY CATHETER. IT WAS STATED, THAT THE DOCTOR SUGGESTED THE CATHETERS ARE DEFECTIVE, AND WILL NOT DRAIN. PATIENT RECEIVED ANTIBIOTICS FOR THE UTI, PER DOCTORS VISIT.

  Patient problems: Urinary Tract Infection

  MAUDE report 10079894 ↗
• InjuryApr 29, 2020Use of Device Problem; Inflation Problem; Use of Device Problem

  IT WAS REPORTED THAT THE BALLOON OVER-INFLATED WHILE INSIDE THE BLADDER. IT WAS ALSO NOTED THAT THE PATIENT HAD A URINARY TRACT INFECTION AND BLOOD CLOTTING AROUND THE SAME TIME OF THE EVENT; HOWEVER, THE PATIENT WAS NOT CERTAIN IF IT IS DUE TO THE CATHETER.

  Patient problems: No Code Available; Patient Problem/Medical Problem; Urinary Tract Infection

  MAUDE report 10011668 ↗
• MalfunctionApr 20, 2020Inaccurate Flow Rate; Defective Device; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WOULD NOT DRAIN AT ALL AND CAUSED ISSUES FOR THE PATIENT. THE USER HAD TO DEFLATE THE BALLOON IN ORDER TO GET IT TO DRAIN AND THE CATHETER HAD TO BE CHANGED CONSTANTLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9978772 ↗
• MalfunctionApr 20, 2020Inaccurate Flow Rate; Insufficient Flow or Under Infusion; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WOULD NOT DRAIN AT ALL AND CAUSED ISSUES FOR THE PATIENT. THE USER HAD TO DEFLATE THE BALLOON IN ORDER TO GET IT TO DRAIN AND THE CATHETER HAD TO BE CHANGED CONSTANTLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9978515 ↗
• MalfunctionFeb 28, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SUPRAPUBIC FOLEY CATHETER LEAKED AROUND THE STOMA AT THE PATIENTS BLADDER AT THE INSERTION POINT. THE PATIENT STATED HE HAD BEEN ON THE SAME CATHETER FOR 30 YEARS, AND DUE TO A PRODUCT BACK ORDER HE HAD BEEN PROVIDED A DIFFERENT SUPRAPUBIC FOLEY CATHETER FROM HIS VENDOR. HE STATED THAT THE CATHETER LEAKED DURING USAGE, AND DID NOT FIT THE SAME WAY HIS NORMAL CATHETER FIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9769897 ↗
• MalfunctionFeb 24, 2020Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE FOLEY WAS SMALLER THAN NORMAL AND IT WAS LEAKING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9745646 ↗