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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7232-24
Medical Device Problem Code Device Damaged Prior to Use (2284)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/28/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
Information was received that the cadd cleo infusion set has a visible needle that was bent.No reported adverse effects.
 
Additional Manufacturer Narrative
Device evaluation summary: one cadd cleo infusion set was returned for investigation in unused condition.Visual inspection detected needle bent in the unit returned.Customer stated issue was confirmed.Problem source was identified as manufacturing.
 
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Brand Name
CLEO INFUSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7962539
Report Number3012307300-2018-00735
Device Sequence Number1572459
Product Code FPA
UDI-Device Identifier30610586028414
UDI-Public30610586028414
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K042172
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/02/2019
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 Health Professional
Device Expiration Date02/07/2023
Device Catalogue Number21-7232-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/14/2018
Supplement Date Received by Manufacturer11/20/2018
Initial Report FDA Received Date10/12/2018
Supplement Report FDA Received Date07/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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