MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INT'L BARD GW SYSTEM; FEEDING DEVICE

Model Number	010061
Medical Device Problem Codes	Material Frayed (1262); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device has been returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of this event indicated that model 10061 feeding device experienced frayed material.This report was received from one source.There was no patient involvement.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
The lot number was provided and the lot history review was performed.One device has been returned to bd for evaluation.The investigation is inconclusive for the guidewire falling out of packaging upon opening as the reported event could not be reproduced in the lab.The clear, plastic ends of the protective sheath were detached from both ends.However the investigation is confirmed for frayed and stretched/elongated guidewire as a portion approximately five inches long at one end of the guidewire was separated from the rest of guidewire by the coil unraveling.The definitive root cause could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of this event indicated that model 10061 feeding device experienced frayed material.This report was received from one source.There was no patient involvement.Patient age, weight, and gender were not provided.

• Brand Name: INT'L BARD GW SYSTEM
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8531946
• Report Number: 3006260740-2019-01040
• Device Sequence Number: 1303635
• Product Code: KNT
• UDI-Device Identifier: 00801741081217
• UDI-Public: (01)00801741081217
• 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,Followup
• Report Date (Section B): 07/23/2019

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: 010061
• Device Catalogue Number: 010061
• Device Lot Number: HUBN0254
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1