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

Model Number	0659230
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 23 cm trifusion catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for partial break/leak on extension leg, as a partial break was identified on the center extension leg tubing just distal to center extension leg hub.The break surface was rough and uneven with visible striations, which is consistent with catheter breaks caused by repeated/prolonged stresses and/or torques applied to the tubing and/or hub.Functional testing revealed that there was leaking at hole during infusion of the center extension leg.One of lateral extension legs was missing and the separation surface on the tubing of the missing extension legs was partially smooth and partially rough with striations mostly aligned towards the center of the lumen.The characteristics of the separation surface are consistent with catheter separation with the aid of a sharp instrument.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 and detachment of device component.This report was received from one source.The device was used inside the patient, with no reported patient injury.The patient involved is (b)(6) years old and weighs (b)(6) lbs.The patient's 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: 8529673
• Report Number: 3006260740-2019-01008
• Device Sequence Number: 19429195
• 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
• Report Date (Section B): 04/18/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1