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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7109-24
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
Information was received that during use of this smiths medical cadd extension sets, fluid leaked at the filter was noted.It was reported that the device was in use with patient for infusion of veletri.No reported adverse effects.
 
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd extension set was returned for analysis in a new condition.The sample was visually inspected under normal conditions of illumination and no discrepancies were found.During analysis, leak test performed using hydrostat vessel and no leaks were detected.Based on the evidence, the complaint was not confirmed, and no fault was found.
 
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Brand Name
CADD EXTENSION SETS
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8453788
Report Number3012307300-2019-01427
Device Sequence Number16430980
Product Code FPA
UDI-Device Identifier10610586034497
UDI-Public10610586034497
Combination Product (Y/N)N
Initial Reporter CountryPO
PMA/510(K) Number
K974013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number21-7109-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/26/2019
Supplement Date Received by Manufacturer07/09/2019
Initial Report FDA Received Date03/26/2019
Supplement Report FDA Received Date08/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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