NEOTREND-L SENSOR N7004-L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-07-20 for NEOTREND-L SENSOR N7004-L manufactured by Diametrics Medical Limited.

Event Text Entries

[399159] The neotrend-l sensor would not insert properly. Blood leaked all the way back to the advancement lock. The plastic y-piece at the tip of the sensor also became detached. No harm or injury to the pt was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612233-2004-00013
MDR Report Key615216
Report Source06
Date Received2004-07-20
Date of Report2004-06-22
Date of Event2004-06-01
Date Mfgr Received2004-06-22
Device Manufacturer Date2004-03-01
Date Added to Maude2005-06-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMISS J. WALTERS
Manufacturer StreetGEORGE STREET, HIGH WYCOMBE
Manufacturer CityBUCKS HP112XJ
Manufacturer CountryUK
Manufacturer PostalHP11 2XJ
Manufacturer Phone494471671
Manufacturer G1DIAMETRICS MEDICAL LIMITED
Manufacturer StreetGEORGE STREET, HIGH WYCOMBE
Manufacturer CityBUCKS HP112XJ
Manufacturer CountryUK
Manufacturer Postal CodeHP11 2XJ
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameNEOTREND-L SENSOR
Generic NameBLOOD GAS MONITORING SYSTEM
Product CodeCCE
Date Received2004-07-20
Returned To Mfg2004-06-28
Model NumberN7004-L
Catalog NumberN7004-L
Lot Number919
ID Number*
Device Expiration Date2005-08-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key604985
ManufacturerDIAMETRICS MEDICAL LIMITED
Manufacturer AddressGEORGE ST. HIGH WYCOMBE, BUCKS. UK HP11 2XJ
Baseline Brand NameNEOTREND-L SENSOR
Baseline Generic NameBLOOD GLAS MONITORING SYSTEM
Baseline Model NoN7004-L
Baseline Catalog NoN7004-L
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2004-07-20

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