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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1; HOTLINE DISPOSIBLES
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SMITHS MEDICAL ASD, INC. LEVEL 1; HOTLINE DISPOSIBLES Back to Search Results
Model Number HOTLINE WARMING SET
Device Problems Disconnection (1171); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2020
Event Type  malfunction  
Event Description
Information received a smiths medical fluid warming level 1 hotline disposables was unable to lock connector to the patient.The lock turned idly but would not lock in place.No patient adverse events reported.
 
Manufacturer Narrative
Evaluation results: one level 1 hotline disposable was returned in used condition.Visual inspection did not reveal any product problems.No fault was found with the device.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
LEVEL 1
Type of Device
HOTLINE DISPOSIBLES
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10159700
MDR Text Key195307346
Report Number3012307300-2020-05988
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier30695085407007
UDI-Public30695085407007
Combination Product (y/n)N
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date11/08/2023
Device Model NumberHOTLINE WARMING SET
Device Catalogue NumberL-70
Device Lot Number3905004
Was Device Available for Evaluation? No
Date Returned to Manufacturer05/28/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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