MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 8.0FR W/-4 VITACUFF PERC; CENTRAL VENOUS CATHETER

Model Number	7711804
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review will be performed.The sample was not returned for evaluation.The investigation is inconclusive for the alleged fracture issue.The root cause could not be determined.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of reported information indicated that model 7711804, central venous catheter, alleged experienced fracture.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

• Brand Name: 8.0FR W/-4 VITACUFF PERC
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9602174
• Report Number: 3006260740-2020-00212
• Device Sequence Number: 2927858
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767
• 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
• 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: 7711804
• Device Catalogue Number: 7711804
• Device Lot Number: RECX3653
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1