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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; INFUSION PUMP
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SMITHS MEDICAL ASD, INC. CADD; INFUSION PUMP Back to Search Results
Model Number 21-7386-24
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2021
Event Type  malfunction  
Event Description
Information was received regarding a cadd administration set.It was reported that device broke in the middle of the night during infusion.The medication did not leak on the patient.The sample was discarded.There was no injury noted.
 
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Brand Name
CADD
Type of Device
INFUSION PUMP
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11548208
MDR Text Key241703847
Report Number3012307300-2021-02393
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517161977
UDI-Public15019517161977
Combination Product (y/n)N
Reporter Country CodeCA
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,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number21-7386-24
Device Catalogue Number21-7386-24
Device Lot Number3935910
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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