MAUDE Adverse Event Report: RYMED IV CVR INVISION PLUS; CONNECTOR

Catalog Number RYM5001

Device Problems Break (1069); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2015

Event Type  Injury  

Event Description

Rn went to assess pt.When she followed her iv line down to give pain medication, she realized propofol tubing was lying on the ground with the iv cap broken off inside the luer lock.Experiencing problems with rymed ((b)(4)) connectors.They are breaking off in the tubing and nurses are finding the broken tubing when they assess the pts.There were 5 instances of this in (b)(6), with lot numbers ro1857 and ro1839.All of the connectors that were broken in those lots were shipped to (b)(6) for testing.The process takes a little over a week.Their qa dept found nothing wrong with the connectors.In the interim, lot number ro1860 was delivered at the first of (b)(6).Since then, three reportable instances of connectors breaking have occurred.Two of those three broken connectors will also be sent to (b)(6) for testing (the other was not available).Our facility has carried the rymed connectors for roughly four years and until now, has never seen a rush of instances like these.The rymed sales rep was contacted and we are told the connectors needed to be changed every 24 hours, which was unclear to out facility until then.We are working on a process to put this action into place.See mw5042740-mw5042743 and mw5042746.

• Brand Name: IV CVR INVISION PLUS
• Type of Device: CONNECTOR
• Manufacturer (Section D): RYMED; franklin TN 37064
• MDR Report Key: 4778592
• MDR Text Key: 5780980
• Report Number: MW5042744
• Device Sequence Number: 2
• Product Code: DTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RYM5001
• Device Lot Number: RO1839
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROPOFOL (DIPRIVAN)
• Patient Age: 80 YR
• Patient Weight: 83