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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ZILVER PTX; CATHETER, BILIARY, DIAGNOSTIC

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WILSON-COOK MEDICAL INC ZILVER PTX; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Catalog Number ZIV6-35-125-7-80-PTX
Device Problems Inadequate Instructions for Healthcare Professional (1319); Device Markings/Labelling Problem (2911); Packaging Problem (3007)
Patient Problem No Information (3190)
Event Date 03/25/2014
Event Type  No Answer Provided  
Event Description
An implant was opened onto the sterile field and the inner wrapper was found to be unsterile.Being unsure of the packaging the nurse questioned the room staff if the inner packaging was sterile or not.The nurse was told it was.After handing the inner package to the scrub nurse the outer package was looked at again and a disclaimer was noticed saying that the inner packaging was not sterile.The scrub nurse was notified right away and it was handed off.The scrub nurse changed gloves and covered the backtable where it had been placed while being removed from its protective plastic tray.It never went up to the surgical site.The packaging should have a warning label placed closer to the area where the outer unsterile package is to be opened.Also a disclaimer on the inner unsterile packaging would be helpful in avoiding this from happening again.When one opens the box, there is a foil pouch, approximately 24" x 13", that is sealed around the four sides, with a peel away notch at one end.On one side, there is a label measuring 7.5 x4", which issues a warning: "this foil pouch and the outer surface of the inner pouch are non-sterile.The contents of the inner pouch are sterile.Use immediately one the pouch has been opened." the reporter did not see the label in the heat of the moment, peeled the foil package open at the notch, and put the unsterile inner package onto the sterile field.They should have removed the inner package, opened it, and the contents of that package could have been placed on the field.
 
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Brand Name
ZILVER PTX
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
WILSON-COOK MEDICAL INC
4900 bethania station rd
winston-salem NC 27105
MDR Report Key3915378
MDR Text Key4489521
Report Number3915378
Device Sequence Number1
Product Code GCA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 06/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? *
Device Operator Invalid Data
Device Catalogue NumberZIV6-35-125-7-80-PTX
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2014
Event Location Hospital
Date Report to Manufacturer07/07/2014
Patient Sequence Number1
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