MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 16F; STANDARD PROFILE REPLACEMENT DEVICES

Model Number	000716
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 716 standard profile replacement device allegedly experienced fluid leak.This information was received from one source.The malfunction involved a patient without consequence.The patient age, weight, and sex were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 716 standard profile replacement device allegedly experienced fluid leak.This information was received from one source.The malfunction involved a patient without consequence.The patient age, weight, and sex were not provided.
Additional Manufacturer Narrative
For this event, the lot number was not reported, therefore the lot history report was not performed.Of the 1 reported malfunctions, 1 device was returned for evaluation.A leak was confirmed for 1 device.A root cause has been determined to be manufacturing related.The device was labeled for single use.Bdpi was notified by your firm on (b)(6)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.

• Brand Name: TRI-FUNNEL REPL GAST 16F
• Common Device Name: STANDARD PROFILE REPLACEMENT DEVICES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8817256
• Report Number: 3006260740-2019-02100
• Device Sequence Number: 14254476
• Product Code: KNT
• UDI-Device Identifier: 00801741037139
• UDI-Public: (01)00801741037139
• 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): 10/03/2019

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: 000716
• Device Catalogue Number: 000716
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/03/2019
• Patient Sequence Number: 1