MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MARQUIS STOPCOCK

Model Number 00884450007297

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.The unit was dye tested and the sterility was found to be compromised.The complaint is confirmed.The root cause is attributed to the packaging and manufacturing process.The device history record was reviewed, and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.

Event Description

The account alleges that the sealing of the packaging is partially opened.

• Brand Name: MARQUIS STOPCOCK
• Type of Device: STOPCOCK
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, ut ; 2084551
• MDR Report Key: 10335873
• MDR Text Key: 202053314
• Report Number: 1721504-2020-00055
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00884450007297
• UDI-Public: 00884450007297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/27/2023
• Device Model Number: 00884450007297
• Device Catalogue Number: S3SNC
• Device Lot Number: H1804153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2020
• 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