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U.S. Department of Health and Human Services

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

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NULL CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameCADD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key11423470
MDR Text Key234995464
Report Number3012307300-2021-01766
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/04/2021
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

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