MAUDE Adverse Event Report: BARD ACCESS SYSTEMS LEONARD 10 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number 0600634

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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; the manufacturing lot number that was provided is incorrect.

Event Description

Per medical services and support (ms&s) the patient stated the catheter was placed (b)(6) 2017.She reported that the white lumen ballooned out near the v of the catheter.She stated the red lumen works well and she just been using the red lumen.The patient expressed that the physicians did not want to repair the catheter.She stated they feel like the repair is not a fix to the ballooning of the catheter.Ms&s advised the patient to contact her physician to have the catheter evaluated for possible repair, informed the white lumen should not be ballooning out when flushed.Informed the patient that the hickman white leg repair kit and the body segment repair kit that would give 2 new ends would be options for repair.Ms&s informed that the catheter is considered repaired once repaired as intended in the instructions for use.

• Brand Name: LEONARD 10 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6659821
• MDR Text Key: 78254011
• Report Number: 3006260740-2017-00886
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051968
• UDI-Public: (01)00801741051968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0600634
• Device Lot Number: HUXE_1755 (INCORRECT)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1