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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
Model Number ADD-ON ASV 12/BX
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Information (3190)
Date of Event 01/07/2020
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that during use of this smiths medical cadd administration sets, the cadd sets had "holes" and medication could not be administrated to the patients because there was a rupture of the treatment.It was reported that the cadd set was changed and port cath was clogged, and the patient was transferred to emergency.No additional adverse effects were reported.
 
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Brand Name
CADD ADMINISTRATION SETS
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key9777174
Report Number3012307300-2020-01820
Device Sequence Number2185018
Product Code FPA
UDI-Device Identifier10610586020162
UDI-Public10610586020162
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K895046
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date08/01/2024
Device Model NumberADD-ON ASV 12/BX
Device Catalogue Number21-7034-24
Device Lot Number3857624
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/05/2020
Initial Report FDA Received Date03/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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