Summary of MedSun Reports Describing Problem Gastrointestinal Tubing and Accessories
MedSun: Newsletter #65, October 2011

Gastrointestinal tubes and accessories are devices consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting or suppressing bleeding of the alimentary tract. These devices may incorporate an integral inflatable balloon for retention or hemostasis (1).

Over the past year, MedSun has received 22 adverse event reports associated with the use of gastrointestinal tubing and accessories (enteral feeding tube devices) manufactured by 6 firms. The firms are Acacia, Bard, Boston Scientific, Corpak Medsystems, Kimberly-Clark, and Vygon. The reports were submitted by 18 MedSun hospitals between August 2010 and August 2011.

The device problems reported included leak, ruptures, misconnections, and other device failures. When these failures occur, the patient often requires an additional medical or surgical procedure to continue therapy. These device failures may also cause pain and discomfort to the patient. Additionally, the patient would have a delay in feeding or altered nutrition. The reported enteral tube problems are shown below:

• Balloon broken/ruptured - 5
• Leaking tube connection - 3
• Tube dislodged – 3
• Tube misconnection - 3
• Balloon leak - 1
• Unable to remove Stylet - 1
• Incorrect tube placement - 1
• Tube discoloration - 1
• Unable to place tube - 1
• Dislodged cuff - 1
• Tube disconnection from patient - 1
• Tube torn - 1

There were no reported patient deaths in these reports. There were 5 instances of patient injuries listed in the 16 reports. The reported injuries are listed below:

• Procedure required to replace tube - 3
• Incorrect tube placement - 1
• Surgery required to replace tube - 1

Of the reports that listed patient age, 10 had a patient age listed as less than 21 years and 6 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 9 reports involved male patients.

The MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recall(s) are associated with gastrointestinal tubing and accessories from the last two years. MedSun reports may or may not be involved in the recall(s) listed.

Recall Number: Z-1203-2010
Date Posted: 03/24/2010
Product: Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2
Code Information: 1015.062M Vygon/Churchill Medical System
Recalling Firm/Manufacturer: Churchill Medical Systems, Inc.; 87 Venture Drive; Dover, New Hampshire 03820-5914
Action: Churchill Medical issued an Urgent: Product Advisory Customer Notification on January 29, 2010 to customers and distributors via overnight delivery. The letter identified the affected product along with the corresponding lot numbers and explained the problem. Accounts are requested to complete the enclosed form and fax it to 215-672-6740, attention Marie Benson. The affected products should be quarantined and customer service should be contacted to arrange return of product. Questions should be directed to Marie Benson at 800-473-5414.
Distribution: Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.
Online Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=88562

The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

MedSun Reports Describing Problems with
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
Kimberly-Clark, Mic-Key button gastrostomy tube NA, NA, AA0025F02 The balloon on the Mic-Key button gastrostomy tube popped out at home. The tube had been placed four months ago. The pt was brought to the ED where the tube was replaced without difficulty. A contrast study revealed good placement and the pt was discharged to home.
Kimberly-Clark, Jejunal Transgastric Feeding Tube NA, 0260-18, NA There was a possible aspiration episode due to the tube feeding being connected to the wrong port. The Gastric feeding tube had three ports. A Bronchoscopy was negative for aspiration, it showed a mucus plug. This was an isolated event.The pt had a mucous plug.
Vygon, Eight French Nutrisafe 2 361.082, VYGONBX50, e 150307FB or 13 The feeding tube came apart from hub when removing extension tubing. It did not impose a safety threat to one of the babies, but other breaks could. An analysis of device will be done. The tube was visually inspected prior to use.
Corpak, Corflo ultra pedi - enteral feeding tube NA, 20-8366, 42589 A six french nasogastric (NG) tube was inserted through patient's nosrtil. When the nurse was checking placement by auscultation, she noted that air was leaking through tube. The NG was taken out and a tear was noted in the NG tube.
Vygon, 60'enteral set with oral syringe adapter AMS-934-1, NA, 1006193 The leaks are occurring at the distal end where the syringe is attached to the tubing. Three separate tubing sets had leaks in same location. All were from the same lot.
Kimberly-Clark, Mic-Key
Mic-Key, NA, NA Seven months ago, the pt was admitted to our facility with a Prepyloric Channel Ulcer type three. The pt underwent a Truncal Vagotomy, Amtrectomy with Bilroth II and a Jejunostomy feeding tube placement. Last month, the pt developed a chronic fisutla of the left anterior abdominal wall. The pt underwent sugery for excision of the fisutla which revealed a foreign body in the fistula tract. The foreign body appeared to be the cuff from the Jejunostomy tube that was previously removed six months ago. The cuff was found to have contributed to the fistula. The cuff was removed in its entirety. The healthcare professional's impression is that the retained cuff from the Jejunostomy tube caused the fisutla.
Vygon, Enteral Feeding Set NA, AMS-372, 1006013 Patient's feeding tube was connected to the peripheral IV instead of the gavage tube. This was a medical misconnection: the enteral feeing tube was compatible with Luer-lock/PIV connector.
CORPAK MedSystems, Extension tubing NA, NA, NA The tubing attachment from the Corpac extension set was added to the new setup. The site was found to be leaking at the change of shift onto the bed linen that had been changed fifteen minutes prior. New tubing was placed. The tubing was found leaking and broke off inside the Jejunal (J)-tube. We were able to pull the broken part out of the J area.
Kimberly Clark UNIBODY GASTROJEJUNAL FEEDING BUTTON, 0270-16-2.5-45, AA0186N10 The pt was scheduled for a gastro-jejunal (GJ) tube change. The caregivers noted that the GJ balloon was not holding any water. Upon further assessment, the GJ tube was noted to be perforated. A snare was utilized to remove it. The Unibody GJ feeding tube was fractured. The distal end had to be retrieved in the jejunem. A new 16FR, 2.5cm stoma length, 45cm Jejunal length GJ feeding button was placed. There was no harm to the pt noted in the documentation.
Kimberly-Clark, MIC-KEY Low Profile Gastrostomy Feeding Tube MIC-KEY, 0120-14-1.7, NA The Nurse administered the tube feeding through the luer lock port. This port is for the balloon that keeps the feeding tube in place. This caused the balloon to rupture, requiring insertion of a replacement tube. This is not the first time this has happened. While we understand the need to do inservices on proper use, different nurses have misidentified and used the balloon port. This has occurred with feedings and/or medications instead of the correct port being used. It is felt that the device could be better labeled. Nurses are mistaking the balloon port as the feeding port. It has now happened more than once. It could be better labeled for those who may not be as familiar with the product in order to prevent similar events.
Kimberly Clark, MIC-KEY Low Profile Gastrostomy Feeding Tube MIC-KEY, NA, NA The medication was instilled into the pt's "Mickey" gastric tube balloon port causing the balloon to fracture. The balloon port was thought to be a medication port. The pt required the insertion of a new tube. The balloon port is not well identified and the staff used the balloon port thinking it was a feeding port. This caused the balloon to break, which causes a need for re-insertion.
Vygon, Six French feeding tube L.75cm ORX-XRO-XRC-PVC feeding tube, NA, NA The RN was attempting to place a six french percutaneous endoscopic (PE) tube for Go Lytely administration for a Bowel Prep with help from a second RN. The RN measured the tube for proper placement, lubricated the tip, and attempted to pass the tube via the right nostril. The RN met with resistance and removed the tube. Upon the tube's removal, the RN's noted small amount of bright red blood in the tube and around the nare. The RN's also noted the tip of the PE tube was no longer present. Approximately one mm of the tip of the PE tube was gone. The pt remained pink, warm and well perfused throughout and after the procedure. The MD was notified. The CXR that was ordered was clear.
Kimberly Clark, Gastrostomy Feeding Tube 12Fr 2.0 cm, 0120-12-2.0, AAO165F02 A premature male infant pt was admitted to the pediatric floor from the OR following an initial gastrostomy (GT)insertion. The pt arrived to the floor in the afternoon. Upon obtaining vital signs (VS) and settling the pt in, the GT was noted to have fallen out and was lying on the bed. The (GT balloon was tested by inflating the balloon and was noted to be leaking). A Foley was ordered to be placed into the stoma site and the pt was taken back to surgery about two hours later for replacement of the GT.
Boston Scientific, Enteral Feeding Tube 6672, NA, NA The pt's spouse is concerned about the pt's percutaneous endoscopic gastrostomy (peg) tube turning black. This peg tube is the second one where this has happened. The pt's spouse has contacted the Dr concerning this manner. The Dr is in contact with another physician concerning this matter. The company is Boston Scientific reference# 6672.
Kimberly-Clark, Mic*Transgastric-Jejunal 15 Fr 45 cm 7-10 ml, 0260-16, AA0102N08 The pt had a gastro-jejunal (GJ) tube replaced last month as her other one had partially come out. The pt returned because the new GJ tube had fallen completely out. They brought the tube in with them and the balloon had burst.
CORPAK MedSystems, CORFLO, ULTRA LITE feeding Tube NA, 20-9551, NA Post placement of a Corpak enteral feeding tube, the x-ray was read by radiologist. The Radiologist notified the nursing staff that the Corpak tube was noted to be in the pt's lung and the pt had a pneumothorax. The Corpak tube was removed and the chest tube was placed by the MD and the pt was chemically paralyzed.
Bard Access Systems, Gastric Decompression Jejunal Feeding Tube 9 French, NA, NA The pt had a percutaneous endoscopic gastrostomy tube (PEG) and received tube feedings but was having high gastric residuals. A Bard jejunal extension feeding tube was placed through the PEG tube to allow post pyloric feeds. High gastric residuals continued and it was noted that the jejunal feeding and gastric suction port of her tube were not being utilized properly. The tube feeding was connected to the suction port rather than the feeding port. The design of the port labeling is difficult to read as the raised letters are small and the same color as the blue tube end and blend in with the tube. Link to the Bard catalog – see page 4. http://www.bardaccess.com/assets/pdfs/other/MC-0029-02_Enteral_Feeding_Tube_Catalog_web.pdf. We have a close up picture of the ports that we can send to MedSun. Availability of device: Device continues to be used in the pt for tube feeding.
CORPAK MedSystems, Cortrak Feeding Tube with Stylet Model# 10 French, 20-9431TRAK, NA The RN reported that they placed a Cortrak device in the pt but were then unable to remove the stylet. The cortrac was removed and new one was placed without incidence.
Kimberly-Clark
Twelve French MIC-KEY Button
12 French, NA, NA During the pt's assessment it was noted that the infant was agitated and pushed against the gastrostomy tube (GT). Mittens were intact on the pt's hands. The pt had pushed against the tubing with an arm and the GT came out of the surgical site. Upon examination, it was noted that the balloon was broken and not intact. The continuous feedings were stopped. A new device was inserted and feedings were restarted.
Kimberly-Clark, Mic-Key* Low-Profile Gastrostomy Feeding Tube NA, 0120-16-1, AA0333F08 A pt was in the pediatric ICU (PICU) for procedural sedation for the placement of a 16 French Mic-Key button and the removal of an existing gastric jejunal (G-J) tube. The pt was G-tube dependent secondary to severe reflux. The pt was sedated with Propofol. The G-tube the pt's family brought with them from the physician's office had a leak in the balloon and was unusable. A 14 French Mic-Key button was used in its place. There were two failed attempts before the third placement was successful.
Kimberly-Clark, MIC NA, 0100-22, AA1059D05 The staff noticed the gastrostomy feeding tube coming out of the pt as numbers were now visible on the tubing. The Surgeon checked the tube and indicated it was dislodged and removed the tube. The balloon was felt to be deflated in error due to unfamiliarity with the device. The pt went to Radiology for injection of the sinus tract for the reinsertion of a new tube that was unsuccessful. The pt was changed to parenteral nutrition until they could return to surgery four days later for a new tube replacement.
Acacia, Inc., Enteral Feeding Tube, 6.5 Fr, 36" NA, ENPV-36-65, A6089 The feeding solution was observed leaking from the connection. The nurse discovered a crack in the connector of the feeding tube. The feeding tube was replaced and the old one was discarded. No significant consequences to pt.

Additional Information:

1. Code of Federal Regulations, “Gastrointestinal Tube and Accessories”. 21 CFR 876.5980 (2010).


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