HUDSON SHERIDAN HVT ENDOTRACHEAL TUBE 7.0MM 5-10314

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 2010-08-18 for HUDSON SHERIDAN HVT ENDOTRACHEAL TUBE 7.0MM 5-10314 manufactured by Teleflex Medical.

Event Text Entries

[1382012] The event is reported as: the cuff would not stay inflated. Defect found during a pretest. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5


[8716843] At this time, it is unknown if a sample will be sent back for investigation. A follow-up investigation report will be sent when completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003898360-2010-00383
MDR Report Key1817189
Report Source06
Date Received2010-08-18
Date of Report2010-08-06
Date of Event2010-08-01
Date Mfgr Received2010-08-06
Device Manufacturer Date2009-01-01
Date Added to Maude2011-01-18
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 FDA0
Event Location0
Manufacturer ContactMICHAEL TAGGART, VP
Manufacturer StreetPO BOX 12600
Manufacturer CityDURHAM NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334901
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPROLONGACION MISION EUSEBIO KINO # 1316,RANCHO EL DESCANSO
Manufacturer CityTECATE, B.C. 21478
Manufacturer CountryMX
Manufacturer Postal Code21478
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameHUDSON SHERIDAN HVT ENDOTRACHEAL TUBE 7.0MM
Generic NameENDOTRACHEAL TUBE
Product CodeLNZ
Date Received2010-08-18
Model NumberNA
Catalog Number5-10314
Lot Number01K0800139
ID NumberNA
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressTECATE MX


Patients

Patient NumberTreatmentOutcomeDate
10 2010-08-18

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