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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7106-24
Device Problem Obstruction of Flow (2423)
Patient Problem Discomfort (2330)
Event Date 03/01/2021
Event Type  malfunction  
Event Description
Information was received indicating that during use of this smiths medical at the end of therapy of this cadd extension sets, air was noticed in the central catheter. It was reported that patient experienced discomfort. No additional adverse effects reported.
 
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Brand NameCADD EXTENSION SETS
Type of DeviceSET, 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 Key12202737
MDR Text Key262653951
Report Number3012307300-2021-07438
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7106-24
Device Catalogue Number21-7106-24
Device Lot Number4016662
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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