MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE TRAY (DUAL-LUMEN) (27CM; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2017
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by ms&s that the facility stated that they attempted to place a retro hemodialysis catheter in a patient and the large introducer kinked and was not able to be utilized for the catheter placement.They stated that a second kit was opened for the procedure and another introducer was used and the placement of the retro hemodialysis catheter was completed.She asked ms&s for another introducer to have on hand.Ms&s informed her that the airguard introducer 16.5 fr could be utilized and informed her that the airguard introducer is valved.No reported patient injury.(b)(6) 2017 it was reported by the facility that the guidewire with the j-hook is what sometimes becomes bent or kinked and has to be removed and another device used.

• Brand Name: RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE TRAY (DUAL-LUMEN) (27CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7015248
• Report Number: 3006260740-2017-01990
• Device Sequence Number: 1014122
• Product Code: MSD
• UDI-Device Identifier: 00801741014079
• UDI-Public: (01)00801741014079
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K022000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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 Model Number: N/A
• Device Catalogue Number: RS27SH32
• 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: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1