MAUDE Adverse Event Report: CORPAK MEDSYSTEMS CORFLO; TUBE, FEEDING

Model Number 20-7368

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 10/15/2016

Event Type  malfunction  

Event Description

The patient had nasogastric (ng) tube replaced in the evening.We were unable to confirm placement with aspirate.A chest x-ray was ordered, noted to be appropriate location.The rn attempted aspirate prior to using tube, aspirate, ph 5, food content noted.Attempted to flush ng tube and rn noted, leaking from external portion of tubing.Upon further investigation, a small crack noted in tubing.The ng tube was removed and replaced without issue.

• Brand Name: CORFLO
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): CORPAK MEDSYSTEMS; 1001 asbury dr.; buffalo grove IL 60089
• MDR Report Key: 6105458
• MDR Text Key: 59981786
• Report Number: 6105458
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20-7368
• Device Catalogue Number: 20-7368
• Device Lot Number: 75045
• Other Device ID Number: H8922073680H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1