BITE PROOF BITE BLOCK 11160

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for BITE PROOF BITE BLOCK 11160 manufactured by B & B Medical Technologies, Inc..

Event Text Entries

[66060106]
Patient Sequence No: 1, Text Type: N, H10


[66060107] While et tube was being advanced, patient became agitated and the blue cap on the zip tie that holds the hollister endotracheal tube holder (bite block) fell into patient's mouth. Rn and respiratory therapist used flashlight to try to locate cap without success. The doctor was notified and ent consult ordered. Before ent arrived, the patient coughed and cap was then visible in mouth and was removed. No harm to patient. Being discussed in systemwide rt mtg re danger of this small tip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6285520
MDR Report Key6285520
Date Received2017-01-30
Date of Report2017-01-18
Date of Event2016-12-22
Report Date2017-01-18
Date Reported to FDA2017-01-18
Date Reported to Mfgr2017-01-18
Date Added to Maude2017-01-30
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBITE PROOF BITE BLOCK
Generic NameSUPPORT, BREATHING TUBE
Product CodeJAY
Date Received2017-01-30
Catalog Number11160
Lot NumberUNKNOWN
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerB & B MEDICAL TECHNOLOGIES, INC.
Manufacturer Address1954 KELLOGG AVE. SUITE 100 CARLSBAD CA 92008 US 92008


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-01-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.