MICROCUFF ADULT ENDOTRACHEAL TUBE 35217 103521703

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-03-16 for MICROCUFF ADULT ENDOTRACHEAL TUBE 35217 103521703 manufactured by Avanos Medical Inc..

Event Text Entries

[183794483] A review of the device history record is in-progress. The actual complaint product was not returned for evaluation. Root cause could not be determined. All information reasonably known as of (b)(6) 2020 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. Avanos medical inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical inc. Complaint database and identified as complaint (b)(4). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc. Product is defective or caused serious injury.
Patient Sequence No: 1, Text Type: N, H10


[183794484] Avanos medical inc. Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient. This is the first of two reports. Refer to 3011270181-2020-00047 for the second report. It was reported that the "pre-filled control balloon maintains the cuff tightness before intubation, and after intubation the patient's air escapes and the cuff leaks. At the last intubation, two tubes from this series were used and both experienced this problem. " "replacement of the intubation tube and intubation through the mouth is planned... Visible swelling in the mouth and throat [was noted]? The tube was removed due to a leak in the cuff (functional cuff before intubation). Another intubation with a new tube was performed - the cuff was leaking again. Another endotracheal tube could not be reinserted into the trachea. " airway patency was maintained with a laryngeal mask until naso-tracheal intubation was performed. 500ml gelaspanu, hydrocortisone 200mg and theospirex 200mg were additionally given.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011270181-2020-00046
MDR Report Key9837930
Report SourceDISTRIBUTOR,FOREIGN,OTHER
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-17
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-16
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 ContactMS. LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1COMMAND MEDICAL NICARAGUA SA
Manufacturer StreetKM 12.5 CARRETERA NORTE PARQUE INDUSTRIAL LAS MERCEDES
Manufacturer CityMANAGUA, MANAGUA
Manufacturer CountryNU
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROCUFF ADULT ENDOTRACHEAL TUBE
Generic NameVAP MICROCUFF ENDOTRACHEAL TUBES
Product CodeBTR
Date Received2020-03-16
Model Number35217
Catalog Number103521703
Lot NumberUM6175XXX
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAVANOS MEDICAL INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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