MAUDE Adverse Event Report: BARD ACCESS SYSTEMS LEONARD 10 FR DL CV CATHETER, WITH SURECUFF TISSUE INGROWTH CUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional 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.A lot history review (lhr) of huzc0285 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility via medwatch that the patient had a hickman catheter placed in the right upper chest per vascular surgery in 2017.It was stated that when flushing the red capped lumen with 10 ml sterile ns flush, after unclamping the clamp, the line blew, tearing open.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak in the hickman catheter was confirmed, and the cause appears to have occurred through use of the device.A 10fr d/l leonard catheter was returned for investigation.A visual observation of the returned sample revealed that the d/l tubing extended 21.9cm from the distal end of the cuff.A 1.0cm longitudinal breach in the tubing was observed in the extension leg with the red connector distal to the clamping oversleeve.The distal end of the breach was curved.A tactual investigation revealed slight weakening in the section of tubing distal to the clamping sleeve.The characteristics of the split in the tubing are consistent with a burst due to over pressurization.This appears to be use related damage.A syringe smaller than 10 ml should not be used to flush or confirm patency.Patency should be assessed with a 10 ml or larger syringe with sterile saline.Upon confirmation of patency, administration of medication should be given in a syringe appropriately sized for the dose.Do not infuse against resistance.Infusion pressures should never exceed 25 psi.Smaller syringes generate more pressure than larger syringes.
Event or Problem Description
It was reported by the facility via medwatch that the patient had a hickman catheter placed in the right upper chest per vascular surgery in 2017.It was stated that when flushing the red capped lumen with 10 ml sterile ns flush, after unclamping the clamp, the line blew, tearing open.

• Brand Name: LEONARD 10 FR DL CV CATHETER, WITH SURECUFF TISSUE INGROWTH CUFF
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6616803
• Report Number: 3006260740-2017-00729
• Device Sequence Number: 781751
• Product Code: LJS
• UDI-Device Identifier: 00801741051968
• UDI-Public: (01)00801741051968(17)200228(10)HUZC0285
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017
• Report Date (Section F): 04/18/2017

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 Expiration Date: 02/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 0600634
• Device Lot Number: HUZC0285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/18/2017