BAXTER CLEARLINK 2C8864S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-06 for BAXTER CLEARLINK 2C8864S manufactured by Baxter Healthcare Corp..

Event Text Entries

[1190170] Picc line infection in neonate, recently changed to baxter clearlink iv tubing. Due to the design of the injection ports, each must be accessed with a syringe during set-up to remove trapped air that is not otherwise removed during the priming process. Prior to this month, nicu had 320 days with no central line infections. Since changing to this tubing there have been 3 cases confirmed and one suspected.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5012330
MDR Report Key1436262
Date Received2009-08-06
Date of Report2009-08-06
Date of Event2009-07-18
Date Added to Maude2009-08-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameBAXTER CLEARLINK
Generic NameBURETROL SOLUTION SET
Product CodeFPA
Date Received2009-08-06
Catalog Number2C8864S
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORP.
Manufacturer AddressDEERFIELD IL 60015 US 60015

Device Sequence Number: 2

Brand NameCLEARLINK EXT SET
Generic NameEXT SET
Product CodeOJA
Date Received2009-08-06
Catalog Number2C8671
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No2
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORP.
Manufacturer AddressDEERFIELD IL 60015 US 60015

Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2009-08-06
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