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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX INTERVENTIONAL IMAGING

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SMITHS MEDICAL ASD, INC. MEDEX INTERVENTIONAL IMAGING Back to Search Results
Model Number MX693R
Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2021
Event Type  malfunction  
Event Description
Information received a interventional imaging|medex high pressure tubing malfunctioned. The report indicated that on two different occasions the tubing ruptured when doing pump pressure injection during a procedure. Rated for 900psi, were using 700-800 psi. No patient injury during procedure was reported.
 
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Brand NameMEDEX
Type of DeviceINTERVENTIONAL IMAGING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6250 shier rings road
dublin OH 43016
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6250 shier rings road
dublin OH 43016
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11685527
MDR Text Key246014722
Report Number3012307300-2021-03262
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMX693R
Device Catalogue NumberMX693R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/04/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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