MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. PRESTO INFLATION DEVICE

Model Number ID4030

Device Problems Retraction Problem (1536); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided so a lot history review was performed.The device was returned to bd for evaluation.The investigation is still currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model id4030 inflation device allegedly experienced incorrect pressure gauge readings.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number was provided and a lot history review was performed.The device was returned to bd for evaluation.The investigation is inconclusive for the alleged pressure gauge issue.The root cause could not be determined.The device is 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 id4030 inflation device allegedly experienced incorrect pressure gauge readings.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

• Brand Name: PRESTO INFLATION DEVICE
• Type of Device: INFLATION DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9598178
• MDR Text Key: 178330444
• Report Number: 2020394-2020-00549
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ID4030
• Device Catalogue Number: ID4030
• Device Lot Number: PID1904045
• Date Manufacturer Received: 03/25/2020
• Patient Sequence Number: 1