MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TUNNELER; TUNNELER SET

Model Number	KW2000
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation; therefore, the investigation of the reported event is inconclusive for component missing.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model kw2000 tunneler set allegedly experienced component missing.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.The age, weight and gender of the patient were not provided.

• Brand Name: TUNNELER
• Common Device Name: TUNNELER SET
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10734871
• Report Number: 2020394-2020-06067
• Device Sequence Number: 3733045
• Product Code: DWS
• UDI-Device Identifier: 00801741129452
• UDI-Public: (01)00801741129452
• 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): 10/26/2020

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: KW2000
• Device Catalogue Number: KW2000
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1