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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 the red lumen was flushed with 10 ml of saline and approximately 2 ml of the saline leaked out onto the patient¿s shirt.The line was inspected and it was reported that a puncture/hole was located in the line.The clamp was moved up above the site where the line had leaked.The catheter was removed and a picc was placed.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged hole in the catheter as no objective evidence has been provided to confirm any alleged deficiency with the catheter.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include over-pressurization, material fatigue, and sharp instrument damage; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).A review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.This ifu warns: do not use the catheter if there is any evidence of mechanical damage or leaking.Accessories and used in conjunction with this device should incorporate luer lock connectors.Avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth edge atraumatic clamps or forceps.Avoid perforating, tearing or fracturing the catheter when using a guidewire.Prior to beginning placement procedure, do the following: examine package carefully before opening to confirm its integrity and that the expiration date has not passed.The device is supplied in a double sterile package and is non-pyrogenic.Do not use if package is damaged, opened or the expiration date has passed.(product is) sterilized by ethylene oxide.Do not resterilize.Inspect kit for inclusion of all components.Do not use the catheter if there is any evidence of mechanical damage or leaking.Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumens.If sutures are used to secure the catheter, make sure they do not occlude or cut the catheter.Clamping the catheter.Selection of the catheter clamp is very important since the catheter is vital to your care.The wrong clamp can damage the catheter.Follow these three rules for clamping: use only smooth-edged clamps.Always clamp the catheter over the reinforced clamping sleeve or tape tab, as instructed by your nurse.Never clamp over the reinforced segment directly adjacent to the connector.(see diagram) follow the directions of your doctor or nurse regarding when to clamp.Most hickman* and broviac* catheters come with pre-attached clamps and reinforced clamping sleeves - do not clamp here.(expiry date 10/2022).
Event or Problem Description
It was reported that the red lumen was flushed with 10 ml of saline and approximately 2 ml of the saline leaked out onto the patient¿s shirt.The line was inspected and it was reported that a puncture/hole was located in the line.The clamp was moved up above the site where the line had leaked.The catheter was removed and a picc was placed.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: 7918331
• Report Number: 3006260740-2018-02636
• Device Sequence Number: 11211880
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 0600630
• Device Catalogue Number: 0600630
• Device Lot Number: HUCR1207
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1