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

Model Number	70-0060-114
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Abscess (1690)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Relationship of device issue to development of abscess is uncertain.Device is expected to be returned and a follow-up report will be filed upon completion of evaluation.
Event or Problem Description
There was a very bad abscess and antibiotics were started.There was leakage at the med port and it was very difficult to move external fixator, tract length 8 cm.
Additional Manufacturer Narrative
The returned device was evaluated and enfit connector cracking was confirmed (this would explain the reported med port leakage).However, relationship of the confirmed failure mode to the reported abxcess is unclear.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
• Common Device Name: GASTROSTOMY FEEDING TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland dr.; tucson AZ 85714 3430
• MDR Report Key: 6956568
• Report Number: 2025851-2017-00002
• Device Sequence Number: 13633046
• Product Code: KNT
• UDI-Device Identifier: 00827002447813
• UDI-Public: (01)00827002447813(17)181213(10)955302
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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: 70-0060-114
• Device Catalogue Number: SBRD-14-ENF
• Device Lot Number: 955302
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 01/25/2018
• 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