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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SET, ADMIN, CADD, SPIKE, 0.2 FLTR, COILED TUBE; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. SET, ADMIN, CADD, SPIKE, 0.2 FLTR, COILED TUBE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7036-01
Medical Device Problem Codes Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/08/2019
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set was cracked by the cassette and causing leaking of iv medication.There were no reported adverse events.
 
Additional Manufacturer Narrative
Returned device was received in damaged physical condition.There was noted damage on the tube that was detected just in a fold of the tube with the housing edge.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
SET, ADMIN, CADD, SPIKE, 0.2 FLTR, COILED TUBE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9587635
Report Number3012307300-2020-00212
Device Sequence Number19734036
Product Code FPA
UDI-Device Identifier10610586020186
UDI-Public10610586020186
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K933390
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) 03/16/2020
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 Model Number21-7036-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/17/2019
Supplement Date Received by Manufacturer02/18/2020
Initial Report FDA Received Date01/14/2020
Supplement Report FDA Received Date03/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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