RUSCH SAFETY CLEAR MAGILL/NO CUFF ET TUBE 100380025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-01-08 for RUSCH SAFETY CLEAR MAGILL/NO CUFF ET TUBE 100380025 manufactured by Teleflex Medical.

Event Text Entries

[17346773] The event is reported as: prior to use of the product (catalog# 100380025), the doctor confirmed that the package was in good condition. When the doctor inserted the endotracheal tube into the patient and connected it to the ventilator, the ventilator alarmed. After that, the doctor found a leakage at the white line marks on the shaft of the device. The doctor changed to another brand to complete the operation successfully. No report of patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2013-00021
MDR Report Key2907081
Report Source01,05,06,07
Date Received2013-01-08
Date of Report2012-12-13
Date of Event2012-12-01
Date Mfgr Received2012-12-13
Date Added to Maude2013-01-31
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 ContactMARGIE BURTON, RN
Manufacturer StreetP.O. BOX 12600
Manufacturer CityDURHAM NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetP.O. BOX 28
Manufacturer CityKAMUNTING, PERAK, WEST MALAYSIA 34600
Manufacturer CountryMY
Manufacturer Postal Code34600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH SAFETY CLEAR MAGILL/NO CUFF ET TUBE
Generic NameNASORAL ET TUBE
Product CodeBSK
Date Received2013-01-08
Catalog Number100380025
Lot Number11LG26
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressPERAK MY


Patients

Patient NumberTreatmentOutcomeDate
10 2013-01-08

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