MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 24FR; FEEDING DEVICE

Model Number	000724
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial mdr pertaining to file #(b)(4) was submitted under the incorrect division scope.The initial mdr should have been submitted under bpv division fda rn #(b)(4), however, the initial emdr and supplemental emdr were submitted under bmd division fda rn #(b)(4) instead.Reference fda rn # (b)(4); mdr number 1018233-2020-02849.Initially submitted on (b)(6) 2020.This emdr under the correct division (bpv division), reflects the initial emdr submitted in the bmd scope.As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiration date: 11/2022.
Event or Problem Description
It was reported that during testing of a feeding device prior to patient use, the balloon allegedly leaked saline fluid.Reportedly, the device was not used and the procedure was successfully performed with another device of the same kind.There a no patient contact.

• Brand Name: TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 24FR
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10040853
• Report Number: 3006260740-2020-01706
• Device Sequence Number: 2986308
• Product Code: KNT
• UDI-Device Identifier: 00801741037177
• UDI-Public: (01)00801741037177
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2020

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: Health Professional
• Device Model Number: 000724
• Device Catalogue Number: 000724
• Device Lot Number: NGDP2010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1