MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE TRAY (DUAL-LUMEN); CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	RS23SH28
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2016
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, at this time, for evaluation.A lot history review (lhr) of asxg0002 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
Facility reported that they found cracking of the red device of a line on the retro percath.Insertion of the catheter was on (b)(6) 2015 and the reported cracking of the red device of the line was found on (b)(6) 2016.No patient injury reported.A repair kit was used on (b)(6) 2016.

• Brand Name: RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE TRAY (DUAL-LUMEN)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6056107
• Report Number: 3006260740-2016-00569
• Device Sequence Number: 543981
• Product Code: MSD
• UDI-Device Identifier: 00801741014062
• UDI-Public: (01)00801741014062(17)170301(10)ASXG0002
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K022000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2016

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: 03/01/2017
• Device Catalogue Number: RS23SH28
• Device Lot Number: ASXG0002
• 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: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1