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	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: no manufacturing issues associated to the reported event were found in the reviewed lot.All process steps were completed per manufacturing procedures, inspection procedures, as documented in work order.There were no manufacturing abnormalities that may have contributed to this complaint.Investigation summary: the device returned was one 10 fr d/l leonard catheter with surecuff.Functional and visual evaluations were performed.The investigation is confirmed for 1074m - ext burst w/o embo and unconfirmed for 1250c - ext leak/break/split w/o embo.As the w-shaped damage on the white extension leg is consistent with burst damage.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.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.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 nurse tried to flush the line and it was reportedly occluded.The nurse had the patient turn their head and cough and was then able to push the plunger some.The nurse applied a little more pressure and the white lumen popped.The line was removed and picc was placed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: no manufacturing issues associated to the reported event were found in the reviewed lot.All process steps were completed per manufacturing procedures, inspection procedures, as documented in workorder.There were no manufacturing abnormalities that may have contributed to this complaint.Investigation summary: the device returned was one 10 fr d/l leonard catheter with surecuff.Functional and visual evaluations were performed.The investigation is confirmed for (b)(4) - ext burst w/o embo and unconfirmed for (b)(4) - ext leak/break/split w/o embo.As the w-shaped damage on the white extension leg is consistent with burst damage.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.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.(b)(4).
Event or Problem Description
It was reported that the nurse tried to flush the line and it was reportedly occluded.The nurse had the patient turn their head and cough and was then able to push the plunger some.The nurse applied a little more pressure and the white lumen popped.The line was removed and 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: 7936694
• Report Number: 3006260740-2018-02722
• Device Sequence Number: 13876295
• 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): 10/25/2018

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: HUBX0597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1