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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® CADD® EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD® CADD® EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information was received indicating that this extension set came apart during infusion. No adverse patient effects were reported.
 
Manufacturer Narrative
Device evaluation: one picture of smiths medical cadd administration set was received and it can be observed an asv valve detached from the tube; it is not possible to appreciate if there are marks of solvent in the tube. No testing or thorough inspection could be performed because no samples were provided for evaluation. Based on the evidence, the complaint was confirmed, and the problem source of the reported to be manufacturing.
 
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Brand NameCADD® CADD® EXTENSION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7593368
MDR Text Key110848673
Report Number3012307300-2018-02108
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2018
Is This a Reprocessed and Reused Single-Use Device?

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