HUMID VENT FILTER COMPACT WITH HME 19401T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-06 for HUMID VENT FILTER COMPACT WITH HME 19401T manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number8040412-2019-00203
MDR Report Key8865513
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-08-06
Date of Report2019-07-15
Date of Event2019-07-14
Date Mfgr Received2019-08-30
Device Manufacturer Date2018-12-28
Date Added to Maude2019-08-06
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 ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPO BOX 28, KAMUNTING INDUSTRIAL ESTATE
Manufacturer CityPERAK, WEST MALAYSIA 34600
Manufacturer CountryMY
Manufacturer Postal Code34600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUMID VENT FILTER COMPACT WITH HME
Generic NameFILTER, BACTERIAL BREATHING CIRCUIT
Product CodeCAH
Date Received2019-08-06
Returned To Mfg2019-08-19
Catalog Number19401T
Lot Number18LT22
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2019-08-06

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