MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUGUIDE COAXIAL; BIOPSY INSTRUMENT

Model Number C2010A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

For the reported malfunctions, two devices were returned.The company is still investigating the issue at this time.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model c2010a biopsy instrument allegedly experienced unsealed device packaging.The information was received from a single source.The reported malfunctions did not involve a patient, therefore, no patient information was provided.

Manufacturer Narrative

H10: the lot number was provided for this malfunction.For the reported malfunctions, two devices were returned to the manufacturer for evaluation.Both the devices were returned with opened package thereby the investigation remains inconclusive for the reported seal issue.Based on the available information, a definitive root cause of the problem could not be determined.The devices were labeled for single use.H10: g4.H11: h6 (method, conclusion).H11:section a through f - the information provided by bd 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 bd.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model c2010a biopsy instrument allegedly experienced unsealed device packaging.The information was received from a single source.The reported malfunctions did not involve a patient, therefore, no patient information was provided.

• Brand Name: TRUGUIDE COAXIAL
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10290088
• MDR Text Key: 199304330
• Report Number: 2020394-2020-04615
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741085079
• UDI-Public: (01)00801741085079
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C2010A
• Device Catalogue Number: C2010A
• Device Lot Number: REDU4582
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1