MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CLARIVEIN IC; CONTINUOUS FLUSH CATHETER

Model Number 85-018-E140S

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2021

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 there was a breach in the packaging resulting in incomplete sterilization of the contents.No patient interaction or injury to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use and use error.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 no exception documents were found.

• Brand Name: CLARIVEIN IC
• Type of Device: CONTINUOUS FLUSH CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 12232918
• MDR Text Key: 263848880
• Report Number: 1721504-2021-00061
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10854339004034
• UDI-Public: 10854339004034
• Combination Product (y/n): N
• PMA/PMN Number: K153502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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 Expiration Date: 02/21/2024
• Device Model Number: 85-018-E140S
• Device Catalogue Number: 85-018-E140S/B
• Device Lot Number: H2046210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1