MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	0600564
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802); Weakness (2145); Numbness (2415); Diaphoresis (2452)
Date of Event	12/19/2016
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.A lot history review (lhr) of huyk0934 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per medwatch report, the facility reported that the patient presented with a cracked hickman catheter, which was initially placed approximately fifteen months ago.It was stated that after the catheter was replaced, the patient appeared to be diaphoretic with left sided numbness/weakness, and a noticeable facial droop.The stroke team was notified.It was stated that the patient suffered an acute stroke.The patient expired four days later.

• Brand Name: HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6341333
• Report Number: 3006260740-2017-00109
• Device Sequence Number: 10984403
• Product Code: LJS
• UDI-Device Identifier: 00801741051852
• UDI-Public: (01)00801741051852(17)190228(10)HUYK0934
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2017
• Report Date (Section F): 01/05/2017

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 Expiration Date: 02/28/2019
• Device Catalogue Number: 0600564
• Device Lot Number: HUYK0934
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• 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: Death
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/05/2017