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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT CADD 100ML EPID CASSETTES; SET, IV, FLUID TRANSFER
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SMITHS MEDICAL ASD, INC. NRFIT CADD 100ML EPID CASSETTES; SET, IV, FLUID TRANSFER Back to Search Results
Catalog Number 21-7600-24
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2024
Event Type  malfunction  
Event Description
It was reported that the medication cassette was occluded in the chemical filling section.This occurred during priming, there was no patient involvement and no harm/adverse event reported.
 
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Manufacturer Narrative
The correction for this report was filed under 9617604-2024-00457 on 5/15/2024.
 
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Brand Name
NRFIT CADD 100ML EPID CASSETTES
Type of Device
SET, IV, FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan ln n
minneapolis, MN 55442
2247062300
MDR Report Key19096671
MDR Text Key340687513
Report Number3012307300-2024-02524
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K162219
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/15/2024
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
Device Operator Other
Device Catalogue Number21-7600-24
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/11/2024
Initial Date Manufacturer Received 03/15/2024
Initial Date FDA Received04/12/2024
Supplement Dates Manufacturer Received04/15/2024
Supplement Dates FDA Received05/15/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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