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

Model Number ID4030

Device Problems Crack (1135); Leak/Splash (1354); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the one reported event, the one device was returned to bd and evaluated.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction event.A review of the event indicated that model id4030 the inflation device allegedly had a suction/aspiration issue.These report was received from one source.Of the one event, did involved patient with no reported patient injury.The patient age, weight and gender not provided.

Manufacturer Narrative

H10: the lot number was not provided, and lot history review was not performed.The device was returned for evaluation.The investigation was confirmed for a crack and leak.A root cause has not been determined.The device was labeled for single use.H10: g4.H11:b5, h6 (results, 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 one malfunction event.A review of the event indicated that model id4030 the inflation device allegedly had a suction/aspiration issue.This report was received from one source.Of the one event, did involved patient with no reported patient injury.The patient age, weight and gender 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: 8514795
• MDR Text Key: 141955840
• Report Number: 2020394-2019-00282
• 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: 07/25/2019

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
• Device Operator: No Information
• Device Model Number: ID4030
• Device Catalogue Number: ID4030
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 06/30/2019
• Supplement Dates FDA Received: 07/25/2019
• Patient Sequence Number: 1