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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SET- FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SET- FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7391-24
Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012); Priming Problem (4040)
Patient Problem No Information (3190)
Event Date 03/04/2020
Event Type  malfunction  
Event Description
Information was received indicating that the cadd administration set was taking 10-20 minutes to prime and it was displaying an air in line issue.There was no reported injury or adverse events.
 
Manufacturer Narrative
Other text: no product sample has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
Manufacturer Narrative
Other text: no product sample has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4).As a result of warning letter cms# (b)(4)., corrected data: corrected information: h6.
 
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Brand Name
CADD ADMINISTRATION SET- FLOW STOP
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
NULL
6000 nathan lane north
minneapolis, mn
Manufacturer Contact
dave halverson
6000 nathan lane north
minneaplois, mn 
3833310
MDR Report Key9925608
MDR Text Key186538934
Report Number3012307300-2020-02523
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027512
UDI-Public10610586027512
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K040636
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,Followup
Report Date 10/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7391-24
Device Catalogue Number21-7391-24
Device Lot Number3815228
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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