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

Model Number	70-0060-116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No patient information is available.Xeridiem is legal manufacturer for the entuit gastrostomy br balloon retention feeding tube.Model number reported is xeridiem part number.Catalog number reported is part number for xeridiem's exclusive distributor for the device, cook medical.Device (gastrostomy tube) could not be evaluated since it was not returned.The anchors referred to in the event description are additional accessories distributed with the entuit gastrostomy tube by cook medical.The anchors are not designed or manufactured by xeridiem.
Event or Problem Description
The patient presented with wounds with pus and necrosis of the skin under the anchors.Patient outcome: disinfection and wound care.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTOR
• Common Device Name: GASTROSTOMY FEEDING TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• MDR Report Key: 7273847
• Report Number: 2025851-2018-00002
• Device Sequence Number: 1014736
• Product Code: KNT
• UDI-Device Identifier: 00827002447820
• UDI-Public: (01)00827002447820(17)181213(10)953402
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2018
• Device Model Number: 70-0060-116
• Device Catalogue Number: SBRD-16-ENF
• Device Lot Number: 953402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention