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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD; ACCESSORIES, PUMP, INFUSION
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SMITHS MEDICAL ASD, INC CADD; ACCESSORIES, PUMP, INFUSION Back to Search Results
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Information was received indicating that immediately on use, the smiths medical cadd accessory kept on breaking and ultimately falling out.The reporter indicated that replacement of the locks did not solve the issue, and that the lock boxes were faulty.The reporter also indicated that the patient had removed the medication and staff caught them.No patient consequences were reported, and no adverse effects were reported.
 
Event or Problem Description
Information was received indicating that immediately on use, the smiths medical cadd accessory kept on breaking and ultimately falling out.The reporter indicated that replacement of the locks did not solve the issue, and that the lock boxes were faulty.The reporter also indicated that the patient had removed the medication and staff caught them.No patient consequences were reported, and no adverse effects were reported.
 
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Brand Name
CADD
Common Device Name
ACCESSORIES, PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9212576
Report Number3012307300-2019-05763
Device Sequence Number3146674
Product Code MRZ
UDI-Device Identifier10610586035029
UDI-Public10610586035029
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K080743
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/20/2019
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
Operator of Device No Information
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/20/2019
Initial Report FDA Received Date10/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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