MAUDE Adverse Event Report: COOK INCORPORATED PEG 24; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	G22636
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Sterility issue - staff noted a hair in the 'sterile' sealed peg kit.Removed from inventory & retained.Not used on a patient.

• Brand Name: PEG 24
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8296480
• Report Number: 8296480
• Device Sequence Number: 1953258
• Product Code: KNT
• UDI-Device Identifier: 00827002226364
• UDI-Public: (01)00827002226364(17)190910(10)W4117103
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2019
• Report Date (Section F): 01/23/2019

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: No Information
• Device Model Number: G22636
• Device Catalogue Number: PEG-24-PULL-S
• Device Lot Number: W4117103
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/23/2019