MAUDE Adverse Event Report: BARD ACCESS SYSTEMS LEONARD CENTRAL VENOUS CATHETER - DUAL LUMEN; 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	11/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.(expiration date: 10/2022).
Event or Problem Description
It was reported that some time post implant of the chronic catheter, the line allegedly burst while flushing clamped above opening.It was further reported the catheter was removed and replaced.There was no reported patient injury.
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: received one dual lumen hickman 10f catheter for evaluation.Visual inspection identified an s-shaped rupture 11 cm from the distal end of the red luer.Functional testing confirmed a leak from the identified rupture.Therefore, based on the s-shaped split the investigation is confirmed for a burst.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: 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.
Event or Problem Description
It was reported that some time post implant of the chronic catheter, the line allegedly burst while flushing clamped above opening.It was further reported the catheter was removed and replaced.There was no reported patient injury.

• Brand Name: LEONARD CENTRAL VENOUS CATHETER - DUAL LUMEN
• 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: 8160949
• Report Number: 3006260740-2018-03572
• Device Sequence Number: 11312248
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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: 12/14/2018
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1