MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 18F; FEEDING DEVICE

Model Number	000718
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, however a photo was provided.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 000718 feeding device reported that the button gastrostomy replacement feeding tube was allegedly digging into the patient's skin.It was further reported that the health care provider suggested to place gauze between the tube and skin; however, the caregiver stated this was not possible.This report was received from one source.This event involved one patient with no reported patient injury.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 000718 feeding device reported that the button gastrostomy replacement feeding tube allegedly experienced improper or incorrect procedure or method.This report was received from one source.This event involved one patient with no reported patient injury.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, however eight electronic photos were provided for review.The investigation is inconclusive for the device digging into the patient¿s skin.The photos showed a tri-funnel device inserted into the patient.The external bolster was visible in the stoma.Redness on the patient¿s skin was observed near the stoma and on part of the skin in the vicinity of the stoma.However, the exact clinical circumstances of the patient and the device are not fully known.The definitive root cause could not be determined based upon available information.The device is labeled for single use.

• Brand Name: TRI-FUNNEL REPL GAST 18F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8525542
• Report Number: 3006260740-2019-00921
• Device Sequence Number: 2689581
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• 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: 000718
• Device Catalogue Number: 000718
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1