MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 14F; FEEDING DEVICE

Model Number	000714
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.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 malfunction.A review of the reported information indicated that model 000714 feeding device allegedly experienced an inflation problem.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: of the one reported device, the lot number was not provided, therefore a lot history review was not performed.The device was returned for evaluation.A leak could not be identified for the 1 device.A root cause has not been determined.The device was labeled for single use.Bdpi was notified by your firm on 9/16/2019 that this procode is no longer eligible for vmsr; however the initial emdr was submitted in the prior quarter when it was eligible for vmsr.This report is the supplemental to that initial report.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000714 feeding device allegedly experienced an inflation problem.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: this procode is no longer eligible for vmsr; however the initial emdr was submitted in the prior quarter when it was eligible.This report is the supplemental to that initial report.The sample was returned for evaluation.The invetigation confirmed for the alleged balloon inflation issue, however the root cause cannot be determined based on the available information.The device was labeled for single use.H10: g4 h11: g1, h6 (results) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000714 feeding device allegedly experienced an inflation problem.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.

• Brand Name: TRI-FUNNEL REPL GAST 14F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8821784
• Report Number: 3006260740-2019-02157
• Device Sequence Number: 3206390
• Product Code: KNT
• UDI-Device Identifier: 00801741037122
• UDI-Public: (01)00801741037122
• 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,Followup
• Report Date (Section B): 01/17/2020

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: 000714
• Device Catalogue Number: 000714
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/31/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/03/2019; 01/17/2020
• Patient Sequence Number: 1