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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD EXTENSION TUBING SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21710624
Device Problem Fluid Leak (1250)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Patient reports side effect of pain in her feet which she states can be intolerable at times. She states she has discussed with md a couple of times. She is still working full-time and sometimes it feels like she is going to pass out from the pain. No shortness of breath. Tylenol does not do much. Advised author would notify md of this also. She also reports the tubing leaking sometimes at the filter closest to her chest. Changing the tubing usually resolves. Patient did not keep packaging for lot number. No further information. Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury ? no; is the actual tubing available for investigation? no; did we replace the tubing? no; did the pt have add'l tubing they were able to switch to? yes, if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? resolved. Reported to (b)(6) by pt/caregiver.
 
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Brand NameCADD EXTENSION TUBING
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key12525436
MDR Text Key273584047
Report NumberMW5104166
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 09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
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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