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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDRAD MEDRAD STELLANT SSS-CTP-SPK

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MEDRAD MEDRAD STELLANT SSS-CTP-SPK Back to Search Results
Model Number SSS CTP SPK
Event Type  Malfunction  
Event Description

The product failure involves the medrad product sss-ctp-spk. We have experienced 3 failures in the coiled low pressure connector tube. The coiled tubing is fractured from orange colored cap connector. No adverse events have occurred as the defect is apparent as soon as the tubing is attempted to be used. It involves lot number 107098, date of manufacture 12/2010.

 
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Brand NameMEDRAD
Type of DeviceSTELLANT SSS-CTP-SPK
Manufacturer (Section F)
MEDRAD
indianola PA
Manufacturer (Section D)
MEDRAD
indianola PA
Device Event Key2138921
MDR Report Key2108090
Event Key2005066
Report NumberMW5020735
Device Sequence Number1
Product CodeDXT
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSSS CTP SPK
Device LOT Number107098
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 05/24/2011 Patient Sequence Number: 1
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