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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AM2 PAT INC.0.9% SODIUM CHLORIDE FOR FLUSH

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AM2 PAT INC. 0.9% SODIUM CHLORIDE FOR FLUSH   Back to Search Results
Lot Number 061219A
Event Date 03/17/2007
Event Type  Other   Patient Outcome  Hospitalization
Manufacturer Narrative

Sample was not available for eval. Retained lot tested. (see add'l scanned pages 1).

 
Event Description

Pt's husband found an unopened syringe with black and brown floating matter. Pt did not inject this syringe per labeling instructions and package insert. Pt developed septicemia. Provider suspects lot contamination.

 
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Brand Name0.9% SODIUM CHLORIDE FOR FLUSH
Manufacturer (Section F)
AM2 PAT INC.
raleigh NC
Manufacturer (Section D)
AM2 PAT INC.
raleigh NC
Manufacturer Contact
dushyant patel
9400 ransdell rd., suite 10
raleigh , NC 27603
(919) 522 -9689
Device Event Key838744
MDR Report Key851849
Event Key814541
Report Number1063652-2007-00001
Device Sequence Number1
Product CodeNGT
Report Source Manufacturer
Source Type Company Representative
Remedial Action Other
Type of Report Initial
Report Date 04/23/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date12/31/2008
Device LOT Number061219A
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/23/2007
Event Location Home
Was The Report Sent To Manufacturer? No
Date Manufacturer Received04/20/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/17/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/10/2007 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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