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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
Model Number 21-7361-24
Device Problems Disconnection (1171); Separation Problem (4043)
Patient Problem No Information (3190)
Event Date 01/14/2021
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical cadd administration set's tubing separated from the luer lock hub.The issue occurred while in patient use and there was no reported adverse event.
 
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Brand Name
CADD ADMINISTRATION SET
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11310179
MDR Text Key231300771
Report Number3012307300-2021-01131
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517191738
UDI-Public15019517191738
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number21-7361-24
Device Catalogue Number21-7361-24
Device Lot Number4048901
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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