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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD M/ML EXTENSION SET 0.2 MICRON SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD M/ML EXTENSION SET 0.2 MICRON SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2018
Event Type  malfunction  
Event Description
Pt reports having an issue with her tubing slipping off of her invision plus connector. Pt reattached the tubing without issues and stated that she had not been off the medication for more than an hour. Pt states she feels okay and that she is in contact with cnss (b)(6), to find a solution to the issue. No other info is known. Dose or amount: 60 inch, frequency: continuous, route: iv. Dates of use: from (b)(6) 2018 to continuing.
 
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Brand NameCADD M/ML EXTENSION SET 0.2 MICRON
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key7650192
MDR Text Key112862441
Report NumberMW5078144
Device Sequence Number0
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2018
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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