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

Catalog Number	5327190
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2017
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 broken clamp was inconclusive since the original sample was not returned for investigation and the returned sample was an unused device that did not exhibit any damage or defects.A functional test of cycling the unused clamps in an open and closed position revealed nothing remarkable.The clamps were hyperextended, but no breaks occurred.It was reported that peroxide was used to clean the device prior to dressing change.Hydrogen peroxide is listed as a recommended cleaning solution for the exit site.The recommended cleaning solution for the catheter luer-lock connectors and end caps is povidone iodine.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of reas0850 showed six other similar product complaint(s) from this lot number.The complaints for this lot number (reas0850) have been reported from the same facility.
Event or Problem Description
It was reported by the facility via the sales rep that the clamp broke when the patient came in for dialysis, it was the venous clamp.On (b)(6) 2017-the facility contact stated that they use peroxide to clean the device prior to dressing change.The facility contact stated the clamps were not brittle.The clamps broke on the back in a "straight clean" line.

• 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: 6575142
• Report Number: 3006260740-2017-00630
• Device Sequence Number: 707252
• Product Code: MSD
• UDI-Device Identifier: 00801741012099
• UDI-Public: (01)00801741012099(17)180428(10)REAS0850
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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: 04/28/2018
• Device Catalogue Number: 5327190
• Device Lot Number: REAS0850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1