MAUDE Adverse Event Report: RYMED TECHNOLOGIES, LLC INVISION-PLUS CLEAR NEEDLELESS CONNECTOR; INVISION NEEDLE-LESS CONNECTOR

Catalog Number 415303

Device Problems Air Leak (1008); Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 05/03/2016

Event Type  Injury  

Event Description

Needless connector on a central line was found to be broken into two pieces.There was a sharp green portion that had detached from the clear cap.The maintenance iv fluids and vasopressor was infusing into the pillow.The patient's port to the central venous line was open to the air.

• Brand Name: INVISION-PLUS CLEAR NEEDLELESS CONNECTOR
• Type of Device: INVISION NEEDLE-LESS CONNECTOR
• Manufacturer (Section D): RYMED TECHNOLOGIES, LLC; 137 third ave. north; franklin TN 37064
• MDR Report Key: 5675311
• MDR Text Key: 45876322
• Report Number: MW5062434
• Device Sequence Number: 1
• Product Code: FPA
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 415303
• Device Lot Number: M00142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 93