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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALINE

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SALINE Back to Search Results
Lot Number 13JUL06062
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 03/26/2014
Event Type  Injury  
Event Description
Inappropriate saline bag filing of questionable substance.
 
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Brand Name
SALINE
Type of Device
SALINE
MDR Report Key3792891
MDR Text Key4369036
Report Number3792891
Device Sequence Number2
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/26/2014
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number13JUL06062
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2014
Distributor Facility Aware Date03/26/2014
Event Location Outpatient Treatment Facility
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/03/2014
Patient Sequence Number1
Patient Age80 YR
Patient Weight87
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