MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET N/A C-TCCS-600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-04-15 for MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET N/A C-TCCS-600 manufactured by Cook Inc.

Event Text Entries

[42807105] (b)(4). Event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10


[42807106] A male patient of unknown age had a segmental resection of the right lower jaw. At post operative day 9, the physician had cleaned and replaced the melker catheter leaving the neck tape loose. When the nurse visited to the patient's room, she found unintended decannulation. The catheter came off when the patient was coughing, because the neck tape was loosely placed. There was no adverse effect to the patient reported.
Patient Sequence No: 1, Text Type: D, B5


[58620458] (b)(4). Event evaluation - during the course of the investigation, a review of the complaint history, quality control, specifications, and instructions for use (ifu) of the product was conducted. The complaint device was not returned. Therefore, no physical examinations could be performed. However, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The ifu provided with the set provides instructions as to the placement of the trach tape on the airway catheter. Based on the information provided the root cause has been determined to be user technique. We will continue to monitor for similar complaints. The appropriate internal personnel have been notified. Per the risk assessment, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[58620459] A male patient of unknown age had a segmental resection of the right lower jaw. At post operative day 9, the physician had cleaned and replaced the melker catheter leaving the neck tape loose. When the nurse visited to the patient's room, she found unintended decannulation. The catheter came off when the patient was coughing, because the neck tape was loosely placed. There was no adverse effect to the patient reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2016-00238
MDR Report Key5581711
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-04-15
Date of Report2016-03-28
Date of Event2016-03-28
Date Facility Aware2016-03-28
Date Mfgr Received2016-03-28
Date Added to Maude2016-04-15
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 ContactMRS. RITA HARDEN
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
Generic NameBWC NEEDLE, EMERGENCY AIRWAY
Product CodeBWC
Date Received2016-04-15
Model NumberN/A
Catalog NumberC-TCCS-600
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-04-15

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