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

Model Number KW2000

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 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
• Type of Device: TUNNELER SET
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10734871
• MDR Text Key: 214643589
• Report Number: 2020394-2020-06067
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00801741129452
• UDI-Public: (01)00801741129452
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: KW2000
• Device Catalogue Number: KW2000
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1