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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT MEDICATION CASSETTE RESERVOIR INTRAVASCULAR ADMINISTRATION SET.

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SMITHS MEDICAL ASD, INC. NRFIT MEDICATION CASSETTE RESERVOIR INTRAVASCULAR ADMINISTRATION SET. Back to Search Results
Model Number 21-7609-24
Device Problem Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2020
Event Type  Malfunction  
Event Description

It was reported the device was being prepared for use and the customer noted the device leaked. Device not used with patient.

 
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Brand NameNRFIT MEDICATION CASSETTE RESERVOIR
Type of DeviceINTRAVASCULAR ADMINISTRATION SET.
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
3-10-15, hakata station east,
minneapolis, MN 55442
MDR Report Key10603195
MDR Text Key209117322
Report Number3012307300-2020-09959
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK162219
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 09/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number21-7609-24
Device Catalogue Number21-7609-24
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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