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Adverse Event Report

BAXTER HEALTHCARE CORP. SOLUTION ADMIN SET W/ CAPPED LUER ACTIVATED VALVE SOLUTION ADMINISTRATION SET   back to search results
Catalog Number 2C8519
Event Date 12/01/2003
Event Type  Malfunction  
Event Description

The facility reported an incident where the tubing was found to have hole in it during priming. No report of patient injury. No further information available.

 
Manufacturer Narrative

The report condition was confirmed and was found to be as a result of the packaging equipment cutting the tubing as it perforates the package.

 
Search Alerts/Recalls

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Brand NameSOLUTION ADMIN SET W/ CAPPED LUER ACTIVATED VALVE
Type of DeviceSOLUTION ADMINISTRATION SET
Baseline Brand NameSOLUTION ADMIN SET W/CAPPED LUER ACTIVATED VALVE
Baseline Generic NameSOLUTION ADMINISTRATION SET
Baseline Catalogue Number2C8519
Baseline Device FamilyCLEARLINK
Baseline Device 510(K) NumberK003225
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed06/12/2002
Manufacturer (Section F)
BAXTER HEALTHCARE CORP.
road 721 km 0.3
p.o box 1389
aibonito PR 00705
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
road 721 km 0.3
p.o box 1389
aibonito PR 00705
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
road 721 km 0.3
p.o. box 1389
aibonito PR 00705
Manufacturer Contact
jenny baethke, assistant mgr
route 120 & wilson road
round lake , IL 60073
(847) 270 -6496
Device Event Key500205
MDR Report Key511238
Event Key485015
Report Number6000001-2004-00051
Device Sequence Number1
Product CodeFPA
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/06/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date09/12/2008
Device Catalogue Number2C8519
Device LOT NumberUR186452
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/15/2003
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2004
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2003
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 Unkown

Database last updated on February 28, 2009

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