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

Catalog Number	IN4130/D
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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¿
• Common Device Name: INFLATION DEVICE
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• MDR Report Key: 9679234
• Report Number: 9616622-2020-00001
• Device Sequence Number: 19525517
• Product Code: MAV
• UDI-Device Identifier: 00884450016756
• UDI-Public: 884450016756
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K122321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1