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

Lot Number 3656172

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Inbound, while filling the cassette, mom noticed the top of the cassette is warped and not attached to the body of the hard plastic cassette.No further details provided.Cadd 100ml, cassette lot #3656172.Is the product compounded? no; is the product over-the-counter? no.

• Brand Name: CASSETTE 100ML W/ FLOWSTOP CAAD
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8155319
• MDR Text Key: 130318185
• Report Number: MW5082058
• 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: 11/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3656172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1