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

Model Number	N/A
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the patient had a fever and was diagnosed as infection.The catheter was removed, but the cuff remained in the patient's body.The patient recovered from the infection as of (b)(6) 2017.Another catheter was implanted via the left subclavian vein.On 3/21/2017 - the catheter was in place for approximately 3 years and 8 months.Additional information regarding the reported infection was requested but not provided.

• Brand Name: SOFT-CELL PC DIALYSIS CATHETER KIT 12.5F X 23 CM(PRE-CURVED) (LONG-TERM) (DL)
• 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: 6446360
• Report Number: 3006260740-2017-00331
• Device Sequence Number: 578993
• Product Code: LFJ
• UDI-Device Identifier: 00801741012402
• UDI-Public: (01)00801741012402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5533230
• 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: 03/30/2017
• 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: Required Intervention