MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD STANDARD KIT (16F) (ST; 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 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 twist in the extension legs could be replicated when the internal lumens of the catheter were subject to a negative pressure.It is unknown if this was a factor in the reported event.One 23cm reliance xk was returned for investigation.Residue from use was observed within the cuff fibers and on the clamps.The extension legs were discolored from use.A tactual investigation revealed weakness in the extension legs underneath the clamps.A functional test revealed that the catheter was patent to infusion and no leaks were observed.When the lumens of the catheter were placed under a negative pressure, the extension legs slightly collapsed, which may have been a factor in the reported event.Another contributing factor is fatigue of the extension legs from repeated clamping.The extension legs were within specification.The catheter may have fatigued from use, but the exact cause of the reported event was unknown.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebw0484 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the catheter was placed on (b)(6) 2017, and "issues" were first reported by the dialysis unit and the catheter was removed last week.He stated the catheter would run fine, but occasionally the extension tubing would twist, which is what eventually caused the catheter to be exchanged.There was no reported patient injury.

• Brand Name: RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD STANDARD KIT (16F) (ST
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7246265
• Report Number: 3006260740-2018-00130
• Device Sequence Number: 19129039
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2018

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: REBW0484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80