MAUDE Adverse Event Report: BARD ACCESS SYSTEMS LEONARD 10 FR DUAL-LUMEN CV CATHETER, WITH SURECUFF TISSUE INGROWTH CUFF, 54CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0600634
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
Per ms&s, the patient's husband stated his wife had a leonard catheter inserted last spring for tpn and lipids.He said that both lumens have been working well until two days ago when the white lumen became sluggish.The husband recalled that they were not taught to aspirate and check blood return prior to the start of the tpn or lipids.On (b)(6) 2017: the husband reported that, "the doctors found a crimp in the line where it enters the skin, and consequently a small rupture in the sluggish lumen.¿.

• Brand Name: LEONARD 10 FR DUAL-LUMEN CV CATHETER, WITH SURECUFF TISSUE INGROWTH CUFF, 54CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7179595
• Report Number: 3006260740-2017-02392
• Device Sequence Number: 164708
• Product Code: LJS
• UDI-Device Identifier: 00801741051968
• UDI-Public: (01)00801741051968
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: Health Professional
• Device Model Number: 0600634
• Device Catalogue Number: 0600634
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1