MAUDE Adverse Event Report: COVIDIEN COVIDIEN ARGYLE FEEDING TUBE 5 FR / CH 1.7 MM X 16; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 460802

Device Problem Malposition of Device (2616)

Patient Problem Discomfort (2330)

Event Date 04/15/2020

Event Type  Injury  

Event Description

Pt was scheduled for a vcug for bilateral hydronephrosis.A 5 fr feeding tube was used as a catheter.After it was placed, it was noted to be coiled in the bladder and they were unable to proceed with the procedure or remove the catheter.A urologist in lubbock was consulted who provided several suggestions on techniques that could be employed in an attempt to remove the catheter.Various wires were passed through the catheter in an attempt to uncoil.The bladder was filled and the catheter was advanced back into the ladder and a stiffer guidewire was passed through the catheter to help straighten the tube.Lidocaine jelly was used to relieve discomfort and relax the proximal sphincter.After approx an hour the radiologist and rnp were able to successfully remove the catheter.The pt did not require further work up or treatment.

• Brand Name: COVIDIEN ARGYLE FEEDING TUBE 5 FR / CH 1.7 MM X 16
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10009251
• MDR Text Key: 189994077
• Report Number: MW5094309
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 460802
• Device Lot Number: 1918305664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO
• Patient Weight: 3