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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET 0.2-MICRON FILTER; SET, ADMINISTRATOR, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD EXTENSION SET 0.2-MICRON FILTER; SET, ADMINISTRATOR, INTRAVASCULAR Back to Search Results
Lot Number 3648276
Device Problem Leak/Splash (1354)
Patient Problems Diarrhea (1811); Headache (1880); Missed Dose (2561); No Code Available (3191)
Event Type  malfunction  
Event Description
Outbound.Patient reports having leaking tubing lately.States on monday (b)(6) 2018 her tubing leaked.States she was in a waiting room where her friend was in surgery, noticed leak in her bag.Cleaned everything up, but had forgotten to bring her supplies with her so was not able to change to new tubing until she got home at midnight.Then she woke feeling headache, diarrhea, flushed, and realized she had not had full dose due to leak.She did not call anyone, stating she is a nurse and felt like she could handle it.Then yesterday, (b)(6) 2018, her tubing leaked again at the filter, and she changed it quickly and everything was fine.States she feels fine.No further details provided.Lot #3648276 expiration date 07/13/2018.Did advised patient to not use expired tubing or supplies and to please throw out her other supplies that are expired.No other information provided.Diagnosis or reason for use: pph.
 
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Brand Name
CADD EXTENSION SET 0.2-MICRON FILTER
Type of Device
SET, ADMINISTRATOR, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key8074332
MDR Text Key127364919
Report NumberMW5081285
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date07/13/2018
Device Lot Number3648276
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Weight107
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