HUDSON RCI IPN044768 5-10316

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-28 for HUDSON RCI IPN044768 5-10316 manufactured by Teleflex Medical.

Event Text Entries

[112592812] Staff has had the ett fortlight adapters popping out issue rear its ugly head again. There were 2 patients in the cvicu today who had an issue. The tubes remain in.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7645555
MDR Report Key7645555
Date Received2018-06-28
Date of Report2018-06-18
Date of Event2018-06-14
Report Date2018-06-18
Date Reported to FDA2018-06-18
Date Reported to Mfgr2018-06-28
Date Added to Maude2018-06-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON RCI
Generic NameTUBE, TRACHEAL
Product CodeBYX
Date Received2018-06-28
Model NumberIPN044768
Catalog Number5-10316
Lot NumberN/A
Device AvailabilityN
Device Age1 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer Address3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-28

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