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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: I FLOW LLC ON-Q SILVERSOAKER; CATHETER, CONDUCTION, ANESTHETIC
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I FLOW LLC ON-Q SILVERSOAKER; CATHETER, CONDUCTION, ANESTHETIC Back to Search Results
Model Number PM030-A
Device Problem No Flow (2991)
Patient Problem No Information (3190)
Event Date 03/04/2014
Event Type  malfunction  
Event Description
Each catheter was flushed by scrub technician before handed to surgeon.Each catheter appeared to work appropriately before insertion as visualized by flushing well.Surgeon then inserted catheters and was unable to get fluid to flush through them.Three different catheters were attempted to be used but did not flush once inserted into tissue.The charge nurse was notified and the surgeon completed case without catheter in place.The company representative was notified and inspected the catheters after the procedure completed.A second company representative called the perioperative manager to get details of the event and requested a medsun report be provided to continue with investigation.A product return kit was sent out by the company and the product will be returned once received.
 
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Brand Name
ON-Q SILVERSOAKER
Type of Device
CATHETER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
I FLOW LLC
43 discovery suite 100
irvine CA 92618
MDR Report Key3689556
MDR Text Key15268073
Report Number3689556
Device Sequence Number2
Product Code BSO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/06/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Model NumberPM030-A
Device Catalogue NumberPM030-A
Device Lot Number0201121070
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/06/2014
Event Location Hospital
Date Report to Manufacturer03/20/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
Patient Age64 YR
Patient Weight102
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