HUDSON ET TUBE HOLDER, SMALL 81803

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-26 for HUDSON ET TUBE HOLDER, SMALL 81803 manufactured by Teleflex Medical Sdn. Bhd..

Event Text Entries

[183724524] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[183724525] During a routine vent check, the respiratory therapist found the upper lip stabilizer had fallen off of the et tube holder. The et tube holder was replaced. No patient injury or harm reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2019-00356
MDR Report Key9378254
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-11-26
Date of Report2019-11-11
Date of Event2019-11-11
Date Mfgr Received2019-11-11
Date Added to Maude2019-11-26
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 ContactVICTORIA SANDLIN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer G1TELEFLEX MEDICAL SDN. BHD.
Manufacturer StreetLOT NO : PT2577 JALEN PERUSAHAAN 4 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 NameHUDSON ET TUBE HOLDER, SMALL
Generic NameTRACHEAL TUBE FIXATION DEVICE
Product CodeCBH
Date Received2019-11-26
Returned To Mfg2019-11-21
Catalog Number81803
Lot Number34789
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL SDN. BHD.
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-26

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