MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. AV SHEATH TUNNELERS; SURGICAL TUNNELER

Model Number AVST2000

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model avst2000.Surgical tunneler allegedly discovered the packaging and internal labels allegedly had the incorrect catalog number printed.This report was received from a single source.This event did not involve a patient, with no patient contact.Age, weight, and gender were not provided.

Manufacturer Narrative

H10: as the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to bd for evaluation.Photos were provided for review.The investigation is unconfirmed for incorrect label.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.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 one malfunction.A review of the reported information indicated that model avst2000 surgical tunneler allegedly discovered the packaging and internal labels allegedly had the incorrect catalog number printed.This report was received from a single source.This malfunction did not involve a patient and there was no patient contact.Age, weight, and gender were not provided.

• Brand Name: AV SHEATH TUNNELERS
• Type of Device: SURGICAL TUNNELER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8812009
• MDR Text Key: 151789124
• Report Number: 2020394-2019-01659
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 00801741090530
• UDI-Public: (01)00801741090530
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AVST2000
• Device Catalogue Number: AVST2000
• Device Lot Number: VTDN0347
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1