MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SEEKER; SUPPORT CATHETER

Model Number	SK9018
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the reported issue.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model sk9018 support catheter allegedly device markings/labelling problem.The information was received from a single source.This malfunction did not involve one patient with no patient consequences.Patients' age, weight and gender were not provided.

• Brand Name: SEEKER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10744700
• Report Number: 2020394-2020-06169
• Device Sequence Number: 3457201
• Product Code: DQY
• UDI-Device Identifier: 00801741067945
• UDI-Public: (01)00801741067945
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: No Information
• Device Model Number: SK9018
• Device Catalogue Number: SK9018
• Device Lot Number: VTDT0427
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/27/2020
• Patient Sequence Number: 1