MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION; GASTROSTOMY TUBE

Model Number 70-0060-224

Device Problem Fracture (1260)

Patient Problem Feeding Problem (1850)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information was available.Event date is estimated based upon report date (event date may be earlier).This mdr groups four complaints which are on the same model number and for the same issue.Entered date is earliest of the four.The remaining three were reported on (b)(6) 2018.Model number is xeridiem part number.Catalog number is part number for cook medical, xeridiem's exclusive distributor for this device.Since lot number is unknown, expiration date and full udi are not known.Implant/explant dates are not known.Devices have not been returned on these four complaints (although a return on the (b)(6) 2018 complaint may still be possible).However, the reported issue is known.A follow-up report will only be provided if a device is returned on the last complaint and a different finding from the known issue results.(b)(6).Date listed is for first of the 4 complaints.The other three were reported on (b)(6) 2018.Devices have not been returned for evaluation on this group of complaints (although a return could still be possible on the (b)(6) 2018 complaint).However, the issue is known and codes selected will reflect this.Date of manufacture cannot be determined since lot number is unknown.

Event Description

The enfit caps and feeding port connections are breaking.There are small cracks in the caps themselves and the threaded flanges are breaking off.The patient is also using tools to get caps unstuck.The caps need to be tightened down hard or else they leak.The enfit that is glued into tube is breaking when patients try to wiggle the enfit connections out of the feeding ports.

Event Description

Same as original report 2025851-2018-00011.

Manufacturer Narrative

This follow-up report adds three additional complaint reports that are from the same healthcare facility, on the same device catalog number, and for the same issue as the original mdr.Date entered for the first additional report.The other two additional reports were received on may 21, 2018 and june 30, 2018.No product was returned on any of these three additional reports.However, the reported issue is already known (enfit connector cracking).Also, as stated on the original mdr, (b)(4) is currently working through production implementation of the change (enfit connector material) that corrects this problem.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• MDR Report Key: 7471001
• MDR Text Key: 107357683
• Report Number: 2025851-2018-00011
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• PMA/PMN Number: K130611/A001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0060-224
• Device Catalogue Number: SBRD-24-ENF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1