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

Model Number	SK15035M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was returned to bd for evaluation.After further evaluation, break was identified on the device during the investigation.Based upon 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 malfunction indicated that model sk15035m support catheter allegedly had a break.This report was received from one source.This malfunction involved a patient with no patient consequences.The patient was a (b)(6) year old female.Weight was not provided for the reported patient.

• Brand Name: SEEKER CROSSING SUPPORT CATHETER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9591626
• Report Number: 2020394-2020-00287
• Device Sequence Number: 3603771
• Product Code: DQY
• UDI-Device Identifier: 00801741067921
• UDI-Public: (01)00801741067921
• 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): 01/15/2020

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: SK15035M
• Device Catalogue Number: SK15035M
• Device Lot Number: VTDV0589
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1