Summary of MedSun Reports Describing Adverse Events Involving Foley Catheters
MedSun: Newsletter #52, September 2010

Conventional and antimicrobial Foley catheters are described in the FDA regulations under 21 CFR 876.5130(a), Urological Catheter and Accessories, as a "flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract." A Foley catheter has also been described as an indwelling balloon-retention catheter used by medical professionals to provide a means of bladder drainage through the urethra. The catheter is for single use, is intended for short-term (less than 30 days) use, and is retained in the bladder with a balloon inflated with a sterile liquid. Sterile water is generally recommended (1).

Over the past year, MedSun has received 27 adverse event reports associated with the Foley Catheter device manufactured by two firms, Bard and Covidien Kendall. The reports were submitted by 20 hospitals between August, 2009 and July, 2010.

The majority of the reported problems include the failure of the catheter’s balloon to deflate, failure to inflate, or failure to maintain inflation. When the balloon is not able to be deflated, the patient will experience discomfort and pain. This problem often requires surgery or a medical procedure to remove the catheter from the patient.

When inflation is not achieved with the device, or the device does not maintain inflation, the patient does not receive the intended therapy. The reported Foley Catheter problems are shown below:
• Balloon not deflating: 6
• Balloon not inflating( or staying inflated): 4
• Pieces of Catheter separated: 4
• Not draining urine: 2
• Difficulty removing Foley catheter: 4
• Unable to remove Foley after deflation: 1
• Catheter became Dislodged: 1
• Failure of temperature sensing probe: 1
• Cuffing of balloon: 1
• Balloon ruptured: 1
• Torn drainage bag: 1

There were no reported patient deaths in these reports. There were 10 instances of patient injuries listed in the 27 reports. The reported injuries are listed below:

• Procedure required to remove Foley catheter: 5
• Surgery required to remove catheter or (retained pieces of catheter): 2
• Pain to Perineum: 1
• Skin redness and sensitivity from excessive manipulation during Foley removal: 1
• Patient placed on antibiotics for difficult catheter removal: 1


Of the reports that listed patient age, 2 had a patient age listed as less than 21 years and 20 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 8 reports involved female patients and a total of 15 reports involved male patients.

The following table lists the MedSun reports that are described in the device problem summary above.


Adverse Event Table
DeviceDevice Identifiers Event Description
C.R. BARD Model# Cat# Lot# KJ8171, 303016A A Foley catheter was placed following a radical Cystoprostatectomy for management of an Orthotopic Ileal Neobladder. Six days later, the patient reported having severe pain in the penis while transferring from the hospital bed to a chair. Upon inspection by the nursing staff, the catheter was noted to be deflated and out of the patient. The catheter bulb torn from the catheter tip and the bulb was not located. The patient underwent an exploratory Cystogram and no remnants were noted to be retained in the patient. A new catheter was placed and the integrity of that catheter remained intact at discharge.
C.R. BARD Model# unknown Cat# 907116 Lot# unknown Foley catheter was placed in patient. When the balloon was deflated and removed from patient, cuffing was present that caused discomfort for the patient. We had a problem with the foleys earlier and we contacted bard. They gave us instructions to discontinue the practice of inflating the balloon prior to insertion. We re-educated staff and changed the practice, however the cuffing and discomfort with removal continued. We discarded all foleys from these lots and the problem continued with the new lots. The company told us it was a problem with our technique. We decided to change the brand of foley we were purchasing and to discontinue using bard. We have done this and have not had any further problems. The change happened a few months ago.
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL DOVER, 20Fr Model# unknown Cat# unknown Lot# 9075141 A 20 Fr Foley was placed in a patient as a Gastrostomy tube, due to unsuccessful attempts to advance Orogastric and Nasogastric tubes. The Foley was advanced through a small hole with 10 ml in the balloon to provide some counter pressure. The Gastrostomy tube, which was a Foley catheter, came out of the stomach and was in the space between the stomach and the abdominal wall. The tube balloon was not inflated. The balloon was checked and it was intact, unruptured, and without a leak. The patient's abdomen contained barium and tube feeds.
C.R. BARD LUBRI-SIL HYDROGEL-COATED SILICONE, 20Fr Model# unknown Cat# 909616M Lot# NC TE1167 A 20 Fr Foley was placed in a patient as a Gastrostomy tube, due to unsuccessful attempts to advance Orogastric and Nasogastric tubes. The Foley was advanced through a small hole with 10 ml in the balloon to provide some counter pressure. The Gastrostomy tube, which was a Foley catheter, came out of the stomach and was in the space between the stomach and the abdominal wall. The tube balloon was not inflated. The balloon was checked and it was intact, unruptured, and without a leak. The patient's abdomen contained barium and tube feeds.
C.R. BARD LUBRI-SIL HYDROGEL-COATED SILICONE Model# unknown Cat# 909616M Lot# NC TE1167 A Foley catheter was used to measure the patient's bladder temperature. It was found to be consistently 36.3 degrees Celsius. For comparison, the temperature was measured with the probe and the oral temperature was found to be 37.0 degrees Celsius. Several additional measurements consistently showed the oral temperature to be 36.7-36.8 degrees Celsius. The representative for the manufacturer was contacted and he indicated that Foley temperature should be at least 0.5 degrees warmer than oral measurements, and not cooler. The temperature measured with the Foley catheter was nearly one degrees Celsius too low, which could mask a fever and preclude treatment.
C.R. BARD Model# unknown Cat# unknown Lot# unknown The Foley balloon does not properly inflate. The item was saved to return to Bard for a proper refund. The catheter was tested under sterile technique before being inserted into the patient. There was no patient contact or harm.
C.R. BARD BARDEX I.C. 16Fr Model# unknown Cat# unknown Lot# NG TB0537 A 16 Fr Foley catheter was inserted. The staff was unable to inflate the Foley catheter with the prefilled 10cc syringe of sterile water. Only 1 cc was used. After 30 minutes, the patient became very uncomfortable. Attempts to withdraw the fluid were unsuccessful. The catheter was cut, and required a guide wire to deflate the balloon
C.R. BARD LUBRICATH Model# unknown Cat# 0165L16 NE8037 Lot# unknown The patient had a Foley catheter placed during gynecological surgery. Upon removal, only 8-10 cc of clear fluid could be withdrawn from the balloon port. Another 10 cc of saline was injected, but it also could not be withdrawn. The balloon port was cut and only a few drops of clear liquid ran out. The Foley was removed by a physician and the balloon was found to be slightly inflated. There was no patient harm.
C.R. BARD Model# unknown Cat# 897216 Lot# NGTE1354 An order was received to discontinue the Foley catheter. The catheter balloon was deflated, and the staff began withdrawing the catheter. Resistance was encountered and the procedure was stopped. A syringe was used to withdraw from the balloon port again. There was no fluid left in the balloon and the catheter could not be removed. The MD had to withdraw the catheter past the point of resistance, which was very uncomfortable as per the patient. When the MD was able to remove the catheter, we noted a "cuff" remained at the balloon. The purchasing manager notified Bard and removed all lot # ngte1354’s from service. The purchasing manager also spoke with the Bard quality control rep. whose response was "that can be a factor with the silicon product."
COVIDIEN Model# unknown Cat# 8887605205 Lot# 9075141 The catheter was inserted in surgery and fell out in the recovery room after the balloon split and ruptured.
C.R. BARD BARDEX I. C. COMPLETE CARE Model# unknown Cat# 903016A Lot# NGTH0974 The Foley catheter was checked prior to patient use and the balloon would not inflate. The inflation occurred in the pigtail where the syringe was inserted, before it got to the main part of the catheter. It looks like the spot where the pigtail goes into the main part of the catheter does not have an opening. When attempting to inflate balloon, the catheter inflated at the instillation port.
C.R. BARD Model# unknown Cat# 8000062 Lot# 365718 This was a confused patient with padded mitts on his hands secondary to pulling at tubes. The nurse entered room to find part of the patient's catheter attached to the drainage bag in the bed. Approximately six inches of the catheter was missing. The catheter had torn with a jagged edge. The patient required surgical removal of the remaining six inch piece of catheter from his bladder.
C.R. BARD LUBRICATH/16 FR COUNCIL TIP Model# unknown Cat# unknown Lot# unknown The urinary catheter balloon deflated spontaneously and the catheter fell out of the patient. A crack was noticed in the catheter near the inflation port. When retesting the balloon after the catheter fell out, water leaked from the crack.
C.R. BARD LUBRI-SIL IC Model# unknown Cat# 300916A Lot# unknown These temperature sensing Foleys are a new product for our hospital. This version is silicone with a silver polymer coating for antimicrobial action. A leak developed and the Foley catheter had to be replaced. There has been more than one event with this problem of having instances of the tip becoming clogged at the duct hole. Another problem is with the probe becoming loose and dangling. These catheters are smaller than the non-silicone product. We had an instance in the ICU where three patients had no urine output. It was determined that the catheters were clogged, and this was not related to the patient's renal status.
C.R. BARD Model# unknown Cat# 1758S Lot# unknown While removing patient's Foley catheter, the tip became stuck at the tip of the patient's penis (the urethral opening). The catheter had to be manipulated and tugged and the patient experienced discomfort. The tip of the patient's penis was red and sensitive after removal was finally achieved. This catheter was the type that is inserted in the OR. There is a hard plastic ring that remains after the balloon is fully deflated. The ring is at the tip of the catheter. Other catheters do not have this hard plastic ring at the tip of them (they are smooth and they do not get caught at the tip of the penis). The catheter was saved and is in the patient's room for inspection.
C.R. BARD Model# unknown Cat# unknown Lot# unknown The Patient had a Foley catheter in place. When the RN attempted to remove the catheter she was unable to deflate the balloon. After attempts by multiple team members, the balloon still would not deflate. In order to remove the Foley catheter, the patient was required to undergo an interventional radiology procedure. The balloon was injected with contrast, which flowed freely into the balloon, but could not be drained. The radiologist punctured the balloon through the patient's abdomen using a 22 gauge spinal needle. After this, the balloon deflated and the catheter was easily removed.
COVIDIEN Model# unknown Cat# unknown Lot# unknown This event was reported by the patient's urologist. The patient underwent a Cystoscopy and a transurethral resection of the prostate at the hospital. After the procedure, the following occurred as per the operative note. A 22-Fr three-way catheter was placed. Light traction was applied and the drainage was crystal clear. The patient went to the recovery room in stable condition. Eight days later, the MD reported to the surgery staff that the patient said his indwelling Foley snapped apart at home and was not caught on anything. A section was left in the patient's bladder. The MD reported that there was no serious harm. The MD did a Cystoscopy in the office to remove it. The patient is fine, per the MD.
C.R. BARD BARDEX Model# unknown Cat# 165808 Lot# unknown An 8 Fr Foley catheter was being removed from a pediatric patient with difficulty. The nurse called a physician to remove the catheter because it would not come out. Following removal, it was noted that the portion which is inflated after insertion and deflated before removal had a ridge. The sterile water had been removed from the balloon. Although removal was difficult, the patient did not sustain any injury. The staff were able to re-create this problem with other catheters of the same lot number.
C.R. BARD Model# unknown Cat# 165816 Lot# unknown The Foley catheter had been inserted during a hospital visit. The patient returned to the urologist's office to have Foley catheter removed. The nurse recalls that the physician drew back on the syringe while draining the balloon. This is contrary to the recommendations from the manufacturer. The physician attributed the problem to a defect in product. The vendor recommends additional in-service on proper techniques.
COVIDIEN Model# unknown Cat# 8887-665241 Lot# 9082389 A triple lumen catheter would not perform continuous bladder irrigation with several tries. The catheter was left in for urine drainage. The catheter is used for continuous bladder irrigation. It is a three port catheter: one for the balloon, one to allow fluid to install and one to allow drainage. The irrigation fluid would not run in. The operative note conveys the following: "a 22 three-way Foley catheter was placed indwelling, but continuous irrigation could not be accomplished despite various efforts. This was removed, and utilizing a catheter guide again, a 24 Foley 3-way catheter was placed, a Kendall polyethylene brand. Again, this could not be irrigated with continuous bladder irrigation. Ultimately the urine was clear enough that we abandoned the continuous bladder irrigation and left the catheter in place."
C.R. BARD BARDEX I.C. INFECTION CONTROL FOLEY CATHETERS Model# unknown Cat# 0165SI Catheter, 920016A Tray Lot# AE0263 The additional “Y” port on the side of the catheter is split in half where the “Y” joins the main catheter. The balloon would not have inflated and there was a possibility of exposure to infection because the sealed system was broken.
C.R. BARD TRAY, FOLEY Model# unknown Cat# 899616 Lot# NG UD0721 The Foley catheter was ordered to be removed. The nurse attempted to deflate the balloon with a syringe and could not. She cut off the hub of the balloon port and attempted to deflate the balloon by aspirating from the balloon port without the hub in place. This also did not work. She then phoned the urologist who attempted to deflate the balloon by inserting a stylet. This was unsuccessful. The urologist then inserted a needle with a syringe beneath the patient's scrotum to burst the balloon through the bladder wall. The catheter was then successfully removed. The nurse pulled another catheter kit, same lot number, and tested it, finding this balloon was also inflatable but could not then be deflated. The risk manager also tried another catheter, with the same lot number, and this balloon worked properly (able to inflate and deflate). There was an internal obstruction of some kind that allowed the inflation of the balloon but not deflation of the balloon.
C.R. BARD LATEX-FREE DRAINAGE BAG FOLEY Model# unknown Cat# 907216 Lot# nguc1924, ngud1854 A Bard Foley catheter was inserted in a patient. The balloon deflated and the catheter needed to be replaced. There was no harm to the patient. It was noted that over the weekend there were several problems with these particular catheter balloons deflating. The catheter trays being used were Bard product #907216, latex-free drainage bag Foley tray with anti-reflux chamber drainage bag, in size 16fr. Two lot numbers were identified as problems: nguc1924 and ngud1854. In addition, two other lot numbers were suspected of having similar problems. These were lot numbers nguc0365 and ngud1853. The balloon on the catheter leaked and deflated, causing the catheter to have to be replaced.
C.R. BARD BARDEX I.C. COMPLETE CARE Model# unknown Cat# unknown Lot# NG UD 1039 Upon testing the Foley bulb before insertion, the bulb inflated but did not deflate.
C.R. BARD. BARDEX I.C. COMPLETE CARE Model# unknown Cat# unknown Lot# unknown Foley balloon did not deflate after initial test. Foley did not come into contact with patient
C.R. BARD BARDEX I.C. COMPLETE CARE Model# unknown Cat# 408607 Lot# 970300 The balloon was inflated with 10cc's of sterile water to test the integrity. It would not deflate when the syringe was used to retract the 10cc's. The balloon remained inflated with water. Several attempts were made to deflate it unsuccessfully. The staff may not be following the mfr's suggestions for how to remove the fluid from the balloon. Pretesting before insertion is the practice here, but I am not sure if removal of the solution is performed the same way by all users. We will alert the education dept here for a possible review with all staff.
BARD UROLOGICAL DIVISION BARDEX I.C. COMPLETE CARE FOLEY TRAY W COLLECTION SYSTEM Model# unknown Cat# unknown Lot# unknown The nurse noted urine on floor. The urine meter bag was torn where the meter flips up to drain into the main bag. The tear is in the same place as a bag previously found to be leaking which was previously reported.
C.R. BARD FOLEY CATHETER Model# unknown Cat# unknown Lot# NGUE0836 A Foley catheter was inserted to the “Y” in the tubing and water was added. The Foley was pulled back until resistance was felt. The patient had a CT of the abdomen and the nurse was told the Foley was in the urethra. A 10cc syringe was used to remove the water so the Foley could be re-adjusted. The water would not drain. The catheter was cut and the water still did not drain. The MD was also unsuccessful in attempting to remove the water from the balloon. The urologist was called. Under ultrasound, a needle was inserted through the penis and into the balloon and then the water drained. The Foley was removed. The patient had Suprapubic catheter placed.

Additional Information:

1. The FDA Public Medical Device Database may be searched for an overview of these devices. This device can be search by visiting:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080884.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun