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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD -EXTENSION SET CADD -EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21710624
Device Problem Leak/Splash (1354)
Patient Problem Headache (1880)
Event Type  Injury  
Event Description
Spontaneous call from patient stating that she was having a headache and then noticed that her tubing is leaking near where the central line is (lot number not available). She has been on medication for at least 5 years and confirms that is not the central line itself or the iv connector and it certainly is the tubing. Advised that she changed the tubing out when this happens as it could affect the dose she is receiving. She stated this has happened 3-4 times before. Asked if she would want cnss to come take a look. She stated not at this time, but if it happens again, she may go that route. She does not want additional supplies at this time either, as she states she has many sets of tubing. Tubing not available for investigation. No time frames were provided for previous tubing issues. Lot numbers unknown for all tubing. Reported to (b)(6) by: patient/caregiver.
 
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Brand NameCADD -EXTENSION SET
Type of DeviceCADD -EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
minneapolis MN
MDR Report Key11669845
MDR Text Key245869632
Report NumberMW5100793
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/09/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21710624
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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