MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE 100ML W/FLOWSTOP; SET, I.V. FLUID TRANSFER

Lot Number 3949573

Device Problems Material Deformation (2976); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/10/2020

Event Type  malfunction  

Event Description

Cadd cassette 100ml w/flowstop lot 3949573 has raised tubing on cassette top.From shipment dated 06/08/2020, two cassettes have looped up tubing between where the tubing comes out of cassette and the green bar is unable to pull the tubing to straighten it and allow it to lay flat on the cassette top.Patient using pre-filled cassettes.No further details provided.

• Brand Name: CADD CASSETTE 100ML W/FLOWSTOP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10178811
• MDR Text Key: 196200558
• Report Number: MW5095098
• Device Sequence Number: 2
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/10/2020
• 2 Devices were Involved in the Event: 1 2

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 Lot Number: 3949573
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR