MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	5327230
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 was discarded after the event occurred.A lot history review (lhr) of reaw0802 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility via customer service that the catheter fell out after the sutures were removed, the sutures are removed after a two week period based on the customer's facility policy.This file applies to lot number reaw0802.

• Brand Name: RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6501588
• Report Number: 3006260740-2017-00431
• Device Sequence Number: 1201831
• Product Code: MSD
• UDI-Device Identifier: 00801741012105
• UDI-Public: (01)00801741012105(17)180630(10)REAW0802
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• 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
• Report Date (Section B): 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: 06/30/2018
• Device Catalogue Number: 5327230
• Device Lot Number: REAW0802
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1