MAUDE Adverse Event Report: COOK MEDICAL COOK MEDICAL ENTUIT GASTROSTOMY FEEDING TUBE

Model Number	EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 18 FR
Health Effect - Clinical Code	Death (1802)
Date of Event	10/20/2018
Type of Reportable Event	Death
Event or Problem Description
Entuit tube placed (b)(6) 2018.Retention balloon inflated.Feeds per tube initiated (b)(6).(b)(6), pt with severe abd pain, ct showed migration of tube outside of stomach and balloon deflated.Pt to operating room for peritoneal lavage.Resulted in peritonitis/sepsis.Pt made dnr and expired (b)(6) 2018.

• Brand Name: COOK MEDICAL ENTUIT GASTROSTOMY FEEDING TUBE
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): COOK MEDICAL ; 750 daniel way; po box 489; bloomington IN 47402 0489
• MDR Report Key: 8028950
• Report Number: 8028950
• Device Sequence Number: 11173418
• Product Code: KNT
• UDI-Device Identifier: 00827002356177
• UDI-Public: (01)00827002356177(17)190915(10)967901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/29/2018
• Report Date (Section F): 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 18 FR
• Device Catalogue Number: G35617
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2018
• 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: Death
• Patient Age: 73 YR
• Patient Weight: 90
• Date Report Sent to FDA: 10/29/2018