MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRIFUSION 23CM, INTER W/MI; CENTRAL VENOUS CATHETERS

Model Number	0659230
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for the one reported event is expected to be 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 event.A review of the events indicated that model 0659230 central venous catheter allegedly experienced a fluid leak.This report was received from one source.The device was used inside of the patient, with no reported patient injury.The patient involved is a (b)(6) year-old, of (b)(6) lbs.Patient gender was not provided.
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; therefore, the investigation is inconclusive for fluid leak as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model 0659230 central venous catheter allegedly experienced a fluid leak.This report was received from one source.The device was used inside of the patient, with no reported patient injury.The patient involved is a twenty-two year-old, of 119 lbs.Patient gender was not provided.

• Brand Name: TRIFUSION 23CM, INTER W/MI
• Common Device Name: CENTRAL VENOUS CATHETERS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8529508
• Report Number: 3006260740-2019-01003
• Device Sequence Number: 19303772
• Product Code: LJS
• UDI-Device Identifier: 00801741036569
• UDI-Public: (01)00801741036569
• 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): 07/23/2019

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: 0659230
• Device Catalogue Number: 0659230
• Device Lot Number: RECQ0213
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1