MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD INFLATION DEVICE.BASIXCOMPAK¿

Catalog Number IN4130/D

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during preparations for an interventional procedure a hole in the outer packaging of an inflation device was identified.A new device was used for this procedure.No patient injury to report.

Manufacturer Narrative

One device was returned for evaluation.The device was examined visually and the complaint was confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and exception documents were found.

• Brand Name: INFLATION DEVICE.BASIXCOMPAK¿
• Type of Device: INFLATION DEVICE
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• MDR Report Key: 9679234
• MDR Text Key: 198898926
• Report Number: 9616622-2020-00001
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00884450016756
• UDI-Public: 884450016756
• Combination Product (y/n): N
• PMA/PMN Number: K122321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: IN4130/D
• Device Lot Number: K1632839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1