MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (PRE-CURVED) (24CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5834190
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
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, as the device remains in the patient.A lot history review (lhr) of revk0230 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the rubber material used by hemostar cvc on the two ports outside the patient's body has memory from the clamps.When the clamps were applied between dialysis treatments (usually two days) the rubber material allegedly keeps the memory of the clamp and does not go back to its original round shape when unclamped.It remains collapsed, flat and narrow.This causes reduction and restriction in blood flow through the ports of the cvc, in turn causes reduction in pump speed used in dialysis.Resulting in reduction in clearance in the dialysis treatment of the patient.The rubber/plastic used to make the two ports should not keep the memory of the clamps.For this patient, there were many dialysis runs that required reversing the two ports, resulting, reduces clearance of those dialysis runs.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (PRE-CURVED) (24CM)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7358363
• Report Number: 3006260740-2018-00475
• Device Sequence Number: 16384461
• Product Code: MSD
• UDI-Device Identifier: 00801741013430
• UDI-Public: (01)00801741013430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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: 5834190
• Device Catalogue Number: 5834190
• Device Lot Number: REVK0230
• Was Device Available for Evaluation?: No
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1