MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN HEMODIALYSIS/APHERESIS CATHETER 13.5F DUAL-LUMEN CATHETER; BLOOD ACCESS DEVICE & ACCESSORIES

Model Number	0600660
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2017
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.A lot history review (lhr) of rezg1417 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that catheter was implanted on (b)(6) 2017.Patient arrived to start the hemodialysis session and in the moment of installation it was observed an "opening" (hole) in the catheter's body.

• Brand Name: HICKMAN HEMODIALYSIS/APHERESIS CATHETER 13.5F DUAL-LUMEN CATHETER
• Common Device Name: BLOOD ACCESS DEVICE & ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6949435
• Report Number: 3006260740-2017-01832
• Device Sequence Number: 11040675
• Product Code: LJS
• UDI-Device Identifier: 00801741037504
• UDI-Public: (01)00801741037504
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

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: 07/28/2020
• Device Model Number: 0600660
• Device Catalogue Number: 0600660
• Device Lot Number: REZG1417
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1