POWER PICC IV LINE 6 FRENCH DL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-22 for POWER PICC IV LINE 6 FRENCH DL * manufactured by Bard Access Systems.

Event Text Entries

[410809] A picc line became clotted and unable to use or draw blood. It was sluggish to flush and the red port was totally occluded. It was discontinued for use and a peripheral iv was started.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number589717
MDR Report Key589717
Date Received2005-03-22
Date of Report2005-03-22
Date of Event2005-03-02
Report Date2005-03-22
Date Reported to FDA2005-03-22
Date Added to Maude2005-04-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NamePOWER PICC IV LINE
Generic NamePICC IV LINE
Product CodeDQO
Date Received2005-03-22
Model Number6 FRENCH DL
Catalog Number*
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityN
Device Age1 YR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key579566
ManufacturerBARD ACCESS SYSTEMS
Manufacturer Address5425 WEST AMELIA EARHART DRIVE SALT LAKE CITY *

Device Sequence Number: 2

Brand NameCLC 2000
Generic NameCATHETER CONNECTOR
Product CodeGCD
Date Received2005-03-22
Model Number*
Catalog Number*
Lot NumberUNK
ID Number*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key579567
ManufacturerICU MEDICAL INC.
Manufacturer Address951 CALLE AMANECER SAN CLEMENTE CA 92673 US

Patients

Patient NumberTreatmentOutcomeDate
10 2005-03-22
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