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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
Catalog Number 21-7394-24
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/23/2017
Event Type  malfunction  
Manufacturer Narrative
One cadd administration set was returned for investigation. The samples were visually inspected at a distance of 12 to 24 inches under normal conditions of illumination. The samples were visually inspected and no abnormalities were observed. Functional testing was performed to look for unusual functions. The tests found no indication of a loose connection. The dimensions of the components were within specification. A root cause could be established since the complaint was not confirmed.
 
Event Description
Information was received indicating that a smiths cadd extension set becomes disconnected from the device. It was also reported that the extension set was difficult to prime. No patient injury or complications were reported in relation to this event.
 
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Brand NameCADD
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
3350 granada avenue north
suite 100
oakdale MN 55128
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key9194216
MDR Text Key169086698
Report Number3012307300-2019-05514
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 10/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7394-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Was Device Evaluated by Manufacturer? Yes
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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