MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TI PORT W/ 6FR CHRONO CATH BASIC; PORT SYSTEM

Model Number 0607301

Device Problems Nonstandard Device (1420); Obstruction of Flow (2423); Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacture for evaluation.Therefore, the investigation is confirmed for obstruction of flow.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 0607301 port system allegedly experienced obstruction of flow, component misassembled and nonstandard device the information was received from a single source.This malfunction did not involve patient as there was no patient involvement.The patient age, weight, and gender were not provided.

• Brand Name: TI PORT W/ 6FR CHRONO CATH BASIC
• Type of Device: PORT SYSTEM
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11211323
• MDR Text Key: 228170534
• Report Number: 3006260740-2021-80005
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026126
• UDI-Public: (01)00801741026126
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2021

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
• Device Operator: No Information
• Device Model Number: 0607301
• Device Catalogue Number: 0607301
• Device Lot Number: REDU4321
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/21/2021
• Type of Device Usage: N
• Patient Sequence Number: 1