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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that upon opening the device packaging, it was noted that the catheter was cracked at the hub.There was no patient involvement.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 10fr d/l leonard catheter segment was returned for evaluation.Visual inspection identified a hole at the distal end of the bifurcate.Functional testing confirmed that when flushing from the red luer the device leaked from the identified hole.Therefore, the investigation is confirmed for the alleged catheter crack at the hub, however, as the crack lead to a leak the investigation will be confirmed for and coded as a leak.The definitive root cause could not be determined based upon the available information.It is unknown if procedural issues contributed to the reported event.Labeling review: the instructions for use (ifu) that was included with the product prescribes the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.On site care instructions states to use alcohol wipes during cleanings.(expiration date: 01/2021).
Event or Problem Description
It was reported that upon opening the device packaging, it was noted that the catheter was cracked at the hub.There was no patient involvement.

• 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: 7807283
• Report Number: 3006260740-2018-02158
• Device Sequence Number: 11075003
• Product Code: LJS
• UDI-Device Identifier: 00801741051968
• UDI-Public: (01)00801741051968
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: Health Professional
• Device Model Number: 0600634
• Device Catalogue Number: 0600634
• Device Lot Number: HUBP0884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR