MAUDE Adverse Event Report: RYMED TECHNOLOGIES, LLC ANTI REFLUX VALVE AVR CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number RYM-7001

Device Problem Material Disintegration (1177)

Patient Problem Insufficient Information (4580)

Event Date 12/03/2022

Event Type  malfunction  

Event Description

Assessment of patient's vascath, arv connected to patient's vascath has a rubber piece that was crumbling into small pieces.

• Brand Name: ANTI REFLUX VALVE AVR CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): RYMED TECHNOLOGIES, LLC
• MDR Report Key: 16149137
• MDR Text Key: 307295146
• Report Number: MW5114301
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RYM-7001
• Device Catalogue Number: BMG415303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: Black Or African American