MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HVA - HEMOSTASIS VALVE ADAPTER

Catalog Number 502017001

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2018

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 distributor alleged that a foreign object was found inside the fluid path of the tubing.This was identified during their production inspection of received product.The device was not sent to a user facility.

Manufacturer Narrative

One unit was returned for evaluation.The device was examined visually.The complaint of contamination in the fluid path is confirmed.The root cause is attributed to the manufacturing process.Fourier transform infrared spectroscopy along with flush testing has shown the contamination to be solely a cosmetic issue and does not impact the form, fit or the function of the device.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: HVA - HEMOSTASIS VALVE ADAPTER
• Type of Device: HEMOSTASIS VALVE ADAPTER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 7289843
• MDR Text Key: 100717588
• Report Number: 1721504-2018-00016
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• PMA/PMN Number: K073035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 502017001
• Device Lot Number: H1243455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1