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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7363-24
Device Problem Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
Information was received indicating that during parenteral nutrition infusion with a smiths medical cadd administration set, it was noted that only half of the medication had gone through, while the pump showed a residual volume of 39 ml.No adverse effects were reported.
 
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Brand Name
CADD
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 Key13059876
MDR Text Key282616416
Report Number3012307300-2021-13149
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517161960
UDI-Public15019517161960
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7363-24
Device Catalogue Number21-7363-24
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 SexMale
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