MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RELIANCE XK DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	5327190
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2017
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 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 reas0850 showed five 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
Facility reported to the sales rep that the clamp is broke on the catheter during the procedure.Device was removed and another device used to complete the procedure.No patient harm was reported.On 4/25/2017 - additional information reported by the sales rep, that the clamp is breaking during dialysis as soon as the nurse is putting pressure on the clamp; causing the clamp to fall apart.The sales rep is not sure if this is when the nurse is clamping or unclamping the device.On 5/11/2017-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 DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6567947
• Report Number: 3006260740-2017-00615
• Device Sequence Number: 14301
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

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?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1