MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20F GUIDEWIRE DELUXE PEG; FEEDING DEVICE

Model Number	000793
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 793 20f guidewire deluxe peg experienced a missing component.Of this event, the device was not used on the patient.The age, sex, and weight of the patient was not provided.The 793 20f guidewire was not returned to the manufacturer limiting investigation.A dhr review was performed on the given lot number and found no nonconformance issues.

• Brand Name: 20F GUIDEWIRE DELUXE PEG
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8533221
• Report Number: 3006260740-2019-01087
• Device Sequence Number: 11195356
• Product Code: KNT
• UDI-Device Identifier: 00801741000478
• UDI-Public: (01)00801741000478
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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?: No
• Operator of Device: No Information
• Device Model Number: 000793
• Device Catalogue Number: 000793
• Device Lot Number: HUCX1870
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1