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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. NRFIT; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7600-24
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2020
Event Type  malfunction  
Event Description
Information was received indicating that the cadd cassette reservoirs - flow stop leaked.When medication was being filled in the cassette, it leaked from the connection part.There was no adverse event reported.
 
Manufacturer Narrative
Other, other text: h3: one cadd cassette reservoir from part number 21-7600-24 was received in used condition within its original package.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.A syringe was used to infuse water into the cassette bag.No leaks were found.Leak testing was reviewed to ensure that measures are within specification, no discrepancies were found.The cause of the reported issue was unable to be confirmed since no occlusion was found on the returned cassette.
 
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Brand Name
NRFIT
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10495434
MDR Text Key205723651
Report Number3012307300-2020-09054
Device Sequence Number1
Product Code LHI
UDI-Device Identifier10610586044007
UDI-Public10610586044007
Combination Product (y/n)N
PMA/PMN Number
K162219
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/10/2021
Device Model Number21-7600-24
Device Lot Number3883724
Was Device Available for Evaluation? No
Date Returned to Manufacturer08/20/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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