TRIPLE LUMEN CATHETER UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-23 for TRIPLE LUMEN CATHETER UNK manufactured by Abbott Critical Care Systems.

Event Text Entries

[17104837] Triple lumen catheter was placed in the o. R. While assessing pt in the critical care unit 4 days later, discovered the port/hub was broken off. Unfortunately ports were discarded upon removal the next day.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number323256
MDR Report Key323256
Date Received2001-03-23
Date of Report2001-02-06
Date of Event2001-01-12
Date Facility Aware2001-01-13
Report Date2001-02-06
Date Reported to Mfgr2001-01-16
Date Added to Maude2001-04-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTRIPLE LUMEN CATHETER
Generic NameTRIPLE LUMEN CATHETER
Product CodeGBP
Date Received2001-03-23
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key312726
ManufacturerABBOTT CRITICAL CARE SYSTEMS
Manufacturer Address2000 REGENCY PARKWAY SUITE 270 CARY NC 27511 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2001-03-23

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