MAUDE Adverse Event Report: RYMED TECHNOLOGIES, INC. INVISION PLUS / RYM 5000; I.V, CONNECTORS

Lot Number M01562

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 01/02/2020

Event Type  Injury  

Event Description

Pt requested different connector from the invision plus rym 5000 for his iv veletri infusion.Stated 3 of them were leaking and blood came out.Md replaced his groshong as precaution, but could not find any cracks.Shipping alternative connectors and asked our rn team to f/u with pt for instruction.Connectors not available for investigation.No further info available.Reported to (b)(4) by pt/caregiver.

• Brand Name: INVISION PLUS / RYM 5000
• Type of Device: I.V, CONNECTORS
• Manufacturer (Section D): RYMED TECHNOLOGIES, INC.
• MDR Report Key: 9706419
• MDR Text Key: 179450392
• Report Number: MW5092973
• Device Sequence Number: 2
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 01/16/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: M01562
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Patient Sequence Number: 1
• Patient Age: 45 YR