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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD INTRAVASCULAR ADMINISTRATION SET

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ST PAUL CADD INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 21-7052-24
Device Problem Audible Prompt/Feedback Problem (4020)
Patient Problem No Information (3190)
Event Date 12/04/2020
Event Type  malfunction  
Event Description
Information was received regarding a cadd extension set. It was reported that the device was alarming with occlusion. This reportedly does not occur when the extension line is removed from the cassette or with other extension lines in the box. It is unknown if there was a patient involved.
 
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Brand NameCADD
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11099746
MDR Text Key224520098
Report Number3012307300-2020-12911
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7052-24
Device Catalogue Number21-7052-24
Device Lot Number4016614
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/04/2020
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

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