MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MEDICATION CASSETTE RESERVOIR, 50 ML; SET, I.V, FLUID TRANSFER

Model Number 21-7301-24

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 05/12/2019

Event Type  Injury  

Event Description

The cadd cassette is composed of a 50 ml bag inside of a hard, tamper-resistant, plastic casing.A small contaminant was noticed in the space between the bag and the plastic casing.It does not appear to be imbedded in any surface.Further concern is that the lot is not on the internal bag nor the plastic casing.The lot can only be seen on the external packaging.This prevented further investigation of devices of the same lot as the identified cassette because th.(b)(4).

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR, 50 ML
• Type of Device: SET, I.V, FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8615815
• MDR Text Key: 145403802
• Report Number: MW5086678
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7301-24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention