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

Lot Number 3965588

Device Problem Gas/Air Leak (2946)

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

Event Date 08/05/2020

Event Type  malfunction  

Event Description

Outbound, patient reported two cadd cassettes have multiple champagne size bubbles after infusion starts.The lot number is 3965588, no further details provided.

• Brand Name: CADD CASSETTE 100 ML W/FLOWSTOP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10395992
• MDR Text Key: 202726510
• Report Number: MW5096009
• Device Sequence Number: 1
• 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: 08/05/2020
• 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: 3965588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR