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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, ADMINISTRATION INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD EXTENSION SET 0.2-MICRON FILTER SET, ADMINISTRATION INTRAVASCULAR Back to Search Results
Lot Number 3635420
Device Problem Leak/Splash (1354)
Patient Problems Anxiety (2328); No Code Available (3191)
Event Type  malfunction  
Event Description
Inbound patient reports that pump extension tubing is leaking at filter. Mother called back on (b)(6) 2018 to voice she and patient are experiencing anxiety, frustration, worry about the leaking tubing. States it happened again yesterday, tuesday (b)(6) 2018. She is voicing frustration that the leaking tubing is still occurring. Wants it fixed, and states she and her daughter do not understand why it is not fixed after 3 months. Confirmed it is still the issue of the slow leak at the back of the imbedded filter in the tubing. No further details provided.
 
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Brand NameCADD EXTENSION SET 0.2-MICRON FILTER
Type of DeviceSET, ADMINISTRATION INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key8014221
MDR Text Key125756502
Report NumberMW5080868
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 10/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3635420
Was Device Available for Evaluation? No
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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