MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SOFT-CELL PC-2 DIALYSIS CATHETER KIT 12.5F X 23 CM (PRE-CURVED) (LONG-TERM) (DUA; BLOOD ACCESS AND ACCESSORIES

Catalog Number	5534230
Health Effect - Clinical Code	Death (1802)
Date of Event	02/16/2016
Type of Reportable Event	Death
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 rezi1333 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 - it was reported per medicon that on (b)(6) 2016 the device was placed into the patient and x-ray revealed no abnormalities.On (b)(6) 2016 dialysis began and it was said the patient took a sudden turn for the worse.The patient expired.Details are currently under investigation.

• Brand Name: SOFT-CELL PC-2 DIALYSIS CATHETER KIT 12.5F X 23 CM (PRE-CURVED) (LONG-TERM) (DUA
• Common Device Name: BLOOD ACCESS AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5504109
• Report Number: 3006260740-2016-00110
• Device Sequence Number: 11036959
• Product Code: LFJ
• UDI-Device Identifier: 00801741012457
• UDI-Public: (01)00801741012457(17)200928(10)REZI1333
• Combination Product (Y/N): N
• PMA/510(K) Number: K871488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: 5534230
• Device Lot Number: REZI1333
• 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: 03/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR