MAUDE Adverse Event Report: CORPAK MEDSYSTEMS, INC. CORFLO ENTERAL FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 40-9366

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/31/2023

Event Type  malfunction  

Event Description

Patient had an nasogastric tube placed.Patient tolerated nasojejunal (nj) feeds until the nj tube was found to be broken at 20 cm from the distal tip, with the proximal portion now out of the patient's nose (unclear when it slipped out).An abdominal x-ray was obtained which showed that the distal 20 cm of the nj tube was retained within the patient's abdomen.Patient was increasingly fussy and uncomfortable with this event, but currently no evidence of free air or other major complication on x-ray.

• Brand Name: CORFLO ENTERAL FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CORPAK MEDSYSTEMS, INC.; 1001 asbury drive; buffalo grove IL 60089
• MDR Report Key: 17170391
• MDR Text Key: 317556809
• Report Number: 17170391
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2023

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 Model Number: 40-9366
• Device Catalogue Number: 40-9366
• Device Lot Number: 20106986
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 120 DA
• Patient Sex: Male
• Patient Weight: 7 KG