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

Model Number ID4030

Device Problems Crack (1135); Suction Problem (2170); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model id4030 inflation device experienced a suction problem; the device would not aspirate correctly.This report was received from a single source.The event involved a patient with no reported injury.The patient¿s age, weight, and sex were unobtainable.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model id4030 inflation device experienced a suction problem; the device would not aspirate correctly.This report was received from a single source.The event involved a patient with no reported injury.The patient¿s age, weight, and sex were unobtainable.

Manufacturer Narrative

The reported malfunction was reassessed for reportability and was determined to be no longer reportable.The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the investigation is confirmed for a crack in the syringe, and for the reported pressurization issue.Based upon the available information, the definitive root cause is unknown.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.

• 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: 8514930
• MDR Text Key: 141956819
• Report Number: 2020394-2019-00284
• 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: 07/23/2019

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: PID1805108
• 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: 07/23/2019
• Patient Sequence Number: 1