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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT; INTRAVASCULAR ADMINISTRATION SET.
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SMITHS MEDICAL ASD, INC. NRFIT; INTRAVASCULAR ADMINISTRATION SET. Back to Search Results
Model Number 21-7605-24
Device Problems Break (1069); Disconnection (1171)
Patient Problem No Information (3190)
Event Date 09/09/2020
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical extension set from the 250ml medication cassette was disconnected during use and the customer noticed that the extension tube's connector broke off.There broken part stayed in the cassette's connector.There was no patient present at the time of the event.
 
Manufacturer Narrative
Other, other text: h3: two pictures of a cadd extension set were received for evaluation.In the picture, it could be seen that the connector is damaged.No testing could be performed because no samples were provided to perform a thorough investigation.
 
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Brand Name
NRFIT
Type of Device
INTRAVASCULAR ADMINISTRATION SET.
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10601135
MDR Text Key209014540
Report Number3012307300-2020-09951
Device Sequence Number1
Product Code LHI
UDI-Device Identifier10610586044113
UDI-Public10610586044113
Combination Product (y/n)N
PMA/PMN Number
K162219
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/28/2020
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 No Information
Device Model Number21-7605-24
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/09/2020
Initial Date FDA Received09/29/2020
Supplement Dates Manufacturer Received10/01/2020
Supplement Dates FDA Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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