MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F; GASTRO-ENTEROSTOMY TUBE

Model Number	000259
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation; therefore, the investigation of the reported event is inconclusive for low flow rate.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000259 gastro-enterostomy tube allegedly experienced restricted flow rate.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, weight and gender of the patient were not provided.

• Brand Name: BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F
• Common Device Name: GASTRO-ENTEROSTOMY TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10737564
• Report Number: 3006260740-2020-03467
• Device Sequence Number: 1114799
• Product Code: KGC
• UDI-Device Identifier: 00801741080852
• UDI-Public: (01)00801741080852
• 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): 10/26/2020

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: 000259
• Device Catalogue Number: 000259
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1