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

Model Number 70-0060-114

Device Problem Torn Material (3024)

Patient Problem Discomfort (2330)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Patient information was not available.Event date is estimated; report date corresponds to when additional information related to reportability was received.Model number is xeridiem part number for the device.Catalog number is part number for xeridiem's exclusive distributor for the device, cook medical.Date provided is date of evaluation; actual return date may have been earlier.Conclusion code is with respect to perstomal abscess which was the reason for reportability.Balloon burst was confirmed but relationship between this failure and the reported peristomal abscess is unclear.

Event Description

The tube was in place less than four weeks - split/tear in balloon.Subsequent information was received as follows: catheter was removed and 14fr halyard gastrostomy device was inserted via existing tract.Gastric aspirate obtained with ph=2.However, as tube has been in place less than four weeks, a tubogram will be required to confirm correct position prior to use.Tube remains at 6cm skin level.Entry site red, painful, inflamed and firm to the touch - peristomal abscess.Currently on clindamycin, gentamicin and flucloxacillin following skin swab.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
• Type of Device: HSDYTPDYP,U YINR
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer (Section G): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer Contact: steve murray ; 4700 s. overland drive; tucson, AZ 85714-3430 ; 5208827794
• MDR Report Key: 7576460
• MDR Text Key: 110329162
• Report Number: 2025851-2018-00015
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 00827002447813
• UDI-Public: (01)00827002447813(17)190119(10)956201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130611/A001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2019
• Device Model Number: 70-0060-114
• Device Catalogue Number: SBRD-14-ENF
• Device Lot Number: 956201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other