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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)
Patient Problems Hemorrhage/Bleeding (1888); Hemorrhage, Cerebral (1889)
Event Date 03/11/2020
Event Type  Injury  
Event Description
Information was received that during use of this smiths medical cadd administration sets, the nurse noticed a dark piece of dried grass like specs floating in the medication bag after mixing (veletri was reconstituted in sterile water).It was reported that the patient was admitted with a stroke but unknown if the product problem caused the stroke.No additional adverse effects were reported.
 
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Brand Name
CADD ADMINISTRATION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, mn 
3833310
MDR Report Key10050217
MDR Text Key190747927
Report Number3012307300-2020-04042
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 Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age31 YR
Patient Weight65
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