MAUDE Adverse Event Report: BARD ACCESS SYSTEMS LEONARD 10 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0600630
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
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 provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that when the nurse flushed the line it ruptured.The line was replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a dhr review is not required, however it was requested.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: the device returned was one 10 fr d/l 90 cm leonard catheter with surecuff complete.Functional, microscopic, tactual, and visual evaluation was performed.A w-shaped split with granular fracture surface was found immediately distal to the bifurcation, which is consistent with a burst.Therefore, the investigation is confirmed for an external leak, more specifically an external burst.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.However, overpressurization, including use of a syringe smaller than 10 ml, is a known cause of bursts and may have contributed to this event.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.(expiry date: 10/2022).
Event or Problem Description
It was reported that when the nurse flushed the line it ruptured.The line was replaced.There was no reported patient injury.

• Brand Name: LEONARD 10 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF
• 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: 8033497
• Report Number: 3006260740-2018-03084
• Device Sequence Number: 1303275
• Product Code: LJS
• UDI-Device Identifier: 00801741051944
• UDI-Public: (01)00801741051944
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 0600630
• Device Catalogue Number: 0600630
• Device Lot Number: HUCR1207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1