MAUDE Adverse Event Report: NULL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Misassembly by Users (3133)

Patient Problem No Information (3190)

Event Date 12/03/2020

Event Type  malfunction  

Event Description

Information was received indicating that during use of a smiths medical cadd cassette, a patient with history of drug dependance broke open a cadd medical cassette and gained access to the medication in the bag.The reporter indicated that patient somehow broke into the cassette that houses the bag with narcotics, this was done by either prying with metal object; knife, screwdriver, etc.Or by placing pump with pole on the floor and stepping/kicking the plastic cassette until it broke and then removed the bag with narcotics.No adverse effects were reported.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 11423470
• MDR Text Key: 234995464
• Report Number: 3012307300-2021-01766
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/05/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1