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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD® ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7034-24
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/16/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event or Problem Description
It was reported that the tubing of a cadd® administration set leaked spontaneously from a manufactured sealed joint, immediately distal to the cassette.The device was being used in a medical daycare.No injury was reported.
 
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Brand Name
CADD® ADMINISTRATION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key6768115
Report Number3012307300-2017-01690
Device Sequence Number1286603
Product Code FPA
UDI-Device Identifier10610586020162
UDI-Public10610586020162
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K895046
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/04/2017
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
Device Catalogue Number21-7034-24
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/18/2017
Initial Report FDA Received Date08/04/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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