MAUDE Adverse Event Report: COVIDIEN LLC KENDALL ENTRIFLEX; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Material Deformation (2976)

Patient Problem Sedation (2368)

Event Date 07/03/2018

Event Type  malfunction  

Event Description

Patient sedated and intubated.Tube feeding running at 20 cc/hr via properly secured, nasally inserted feeding tube.Rn unable to push meds through tube.Tube was removed and it was then noted tube permanently kinked at 8 cm.Kink has caused the tube to be permanently folded over on itself.When manually straightened i can pull/push air/fluid through the tube but when i'm not manually straightening the tube it folds back over on itself and will not work.Line was placed about 1700 today and failed at 2330.Unable to obtain lot # (dug through trash and can't find package).Multiple lot numbers in stock on unit.

• Brand Name: KENDALL ENTRIFLEX
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7665761
• MDR Text Key: 113298471
• Report Number: 7665761
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/04/2018,07/03/2018

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
• 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: 07/04/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 70