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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
Catalog Number 21-7231-24
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/01/2019
Event Type  Injury  
Event Description
Information was received indicating that cadd cleo infusion set's needle broke but was able to be located and removed.The patient received the remaining of the life sustaining infusion by replacing the infusion set's tubing.
 
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Brand Name
CADD CLEO INFUSION SETS
Type of Device
SET, 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
minneaplois, MN 55442
7633833310
MDR Report Key8609850
MDR Text Key145039010
Report Number3012307300-2019-02406
Device Sequence Number1
Product Code FPA
UDI-Device Identifier30610586028407
UDI-Public30610586028407
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other
Type of Report Initial
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/28/2023
Device Catalogue Number21-7231-24
Device Lot Number78X033
Was Device Available for Evaluation? No
Date Manufacturer Received04/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
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