MAUDE Adverse Event Report: TUBES, GASTROINTESTINAL (AND ACCESSORIES); SYRINGE, PISTON

Device Problem Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Dignishield system tubing misconnections remain an important cause of severe patient injury and death.Tubes that serve different functions can be connected easily using luer lock connectors and can also be constructed using adapters, catheters, or tubing.Luer connections make it very easy to connect unrelated tubing, which poses a very real danger.The bard dignishield device is a fecal management system that utilizes luer connections.The dignishield device comes with a warning: "there is a potential risk of misconnections with connectors from other healthcare applications, such as intravenous equipment, breathing and driving gas systems, urethral/urinary, limb cuff inflation, neuraxial devices and other enteral and gastric applications." a 60 ml luer-lock syringe is provided with the device that is intended to aid in inflating the device using water.It also has several connection sites (inflation port, irrigation port, flush port) for various purposes throughout use of the product.In addition to inflating the device during application, the ports serve for medication delivery, flushing the tubing, and removal of the system.There are many opportunities for error with the system with such connections.One such opportunity comes from the system utilizing an oral tip syringe to remove specimens from the tubing system.This is the recommended syringe and could be easily confused.Another issue is the use of the luer lock system itself.The system is designed to be universal and less complicated to use, however the disadvantage comes from the fact that while easy to use, it is also easy to make mistakes and connect tubes that should not be connected to one another or attach syringes to the wrong connections and deliver substances through the wrong route of administration.The luer-lock syringes used with dignishield are the same types of syringe connections for iv administration.While the syringe does not display any writing that says "iv-use only", misconnections could still occur between systems (iv and dignishield) easily.Some treatments that are commonly given through a fecal management system are medications such as vancomycin, lactulose, and kayexalate.These could easily be given via the wrong route due to the syringes they would be provided in as well.Another issue that could arise would be simply administering fluids or medications into the wrong intake port on the device such as injecting medications into the flush port when they should be administered into the irrigation port.Another administration error could occur if inserting medication or excessive fluid into the inflation port.This could cause the device to leak with too much fluid volume inserted.This error could easily be made especially since the labeling on the ports themselves is not as clear as with other devices such as the flexi-seal system which has an indicator that changes color when too much fluid has been inserted.The 60 ml syringe does have a red band around the syringe at the 45 ml mark that displays the words "do not inflate the balloon more than 45", however the dignishield ports are minimally labeled.The irrigation port simply says '"lrig" versus the flexi-seal port saying irrigation/meds which would be more clear so that you know to administer medications correctly.It is important to ensure proper use of the dignishield device while ensuring patient safety as well.There has been no error with the device currently, however the system appears to have many safety flaws that could potentially result in errors and/or patient harm.(b)(4).

• Brand Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 9519754
• MDR Text Key: 172879016
• Report Number: MW5091887
• Device Sequence Number: 2
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 12/24/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1