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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD BLUE-STRIPED IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD BLUE-STRIPED IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7036-01
Medical Device Problem Codes Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/02/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
 
Event or Problem Description
Information was received indicating that a smiths medical cadd blue-striped iv administration set was leaking at the air eliminating filter.It was reported that priming the tubing was not possible due to the leak.No adverse effects were reported.
 
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Brand Name
CADD BLUE-STRIPED IV ADMINISTRATION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8679328
Report Number3012307300-2019-03440
Device Sequence Number13866673
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 Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 06/07/2019
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 Expiration Date12/20/2023
Device Model Number21-7036-01
Device Catalogue Number21-7036-01
Device Lot Number3730649
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/17/2019
Initial Report FDA Received Date06/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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