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

Model Number 70-0060-118

Device Problem Fracture (1260)

Patient Problem Feeding Problem (1850)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

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.Device samples have been returned on 2 of the 4 complaints and one more returned sample is anticipated.Date of return is estimated based on date of evaluation.A follow-up report will only be provided if there is a different finding on the last return.Initial reporter listed is for 3 of the 4 complaints.The other one was reported by (b)(6).Date listed is for first of the 4 complaints.The other three were reported on (b)(6) 2018.Evaluation was completed on returned devices from two of the complaints.One more device return is anticipated.Date of manufacture cannot be determined since lot number is unknown.Conclusion code indicates the known issue which is resolved by change recently cleared in k171347.Xeridiem is presently working through production implementation of this change.

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 connection out of the feeding ports.

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 29, 2018.Product was returned on two of the three additional reports and the enfit connector cracking failure was confirmed but with no new finding as compared to the original mdr.As stated in the original mdr, xeridiem is currently working through production implementation of the change (enfit connector material) that corrects this problem.

Event Description

Same as original report 2025851-2018-00008.

• 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: 7463141
• MDR Text Key: 107097400
• Report Number: 2025851-2018-00008
• 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: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0060-118
• Device Catalogue Number: SBRD-18-ENF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• 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