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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD CLEO INFUSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 7231
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
Information received indicating that this cadd cleo infusion set did not have seal which may cause the needle to be exposed. The number of affected quantity is unknown at this time. No adverse effects reported.
 
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Brand NameCADD CLEO INFUSION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key8837577
MDR Text Key152529319
Report Number3012307300-2019-02991
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 07/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7231
Device Catalogue Number21-7231-24
Device Lot Number77X187
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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