MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD STANDARD KIT (16F); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5323230
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 remains in the patient.A lot history review (lhr) of rebs1588 showed one other similar product complaints from this lot number.
Event or Problem Description
A (rn) registered nurse at the facility reported to the sales rep that the plastic extension tubing of the reliance xk catheter twisted and kinked.It was stated that an unusually high rate was noted when dialyzing through the catheter.The rn expressed it seems as though the tubing is much thinner than what the staff has previously noticed with the same catheters.There have not been any changes with the catheter maintenance, cleansing or catheter locking procedures.No patient injury reported.This file addresses patient two of lot rebs1588.

• Brand Name: RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD STANDARD KIT (16F)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7164103
• Report Number: 3006260740-2017-02370
• Device Sequence Number: 1890686
• Product Code: MSD
• UDI-Device Identifier: 00801741011993
• UDI-Public: (01)00801741011993
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/04/2018

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: 5323230
• Device Catalogue Number: 5323230
• Device Lot Number: REBS1588
• 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: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 127