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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; ADMINISTRATION SETS
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SMITHS MEDICAL ASD, INC. CADD; ADMINISTRATION SETS Back to Search Results
Model Number FLOW STOP
Device Problem Obstruction of Flow (2423)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information received a smiths medical ambulatory infusion pumps|cadd administration sets - flow stop were reported to have occlusion issues.Also reported same issue with different lot numbers.No adverse patient events reported.
 
Manufacturer Narrative
H3: 44 cadd administration set were received for evaluation in their original closed packaging inside plastic bags and transit cartons.The returned samples were visually inspected at 12" to 16" under normal conditions of illumination.No defects were observed.Colored water was passed through the 44 units to check for occlusion.No occlusion was detected in the samples and the reported issue was unable to be confirmed.There was no fault found with the returned samples.
 
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Brand Name
CADD
Type of Device
ADMINISTRATION SETS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11065993
MDR Text Key223431836
Report Number3012307300-2020-12712
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517161960
UDI-Public15019517161960
Combination Product (y/n)N
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberFLOW STOP
Device Catalogue Number21-7363-24
Device Lot Number3971691
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received03/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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