CORTRAK ENTERAL ACCESS SYSTEM 20-0950 104720102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for CORTRAK ENTERAL ACCESS SYSTEM 20-0950 104720102 manufactured by Avanos Medical Inc..

Event Text Entries

[184849892] The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. All information reasonably known as of 24 mar 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


[184849893] Avanos medical inc. Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients. This is the first of two reports. Refer to 3011270181-2020-00050 for the second report. It was reported by the user facility that "there was 2 lung placements but it was user error... There was no patient injury or pneumothorax to report. " additional information received on 04-mar-2020 indicated that a cortrak device was used; no further details were available. Additional information received on 05-mar-2020 indicated that the device serial numbers were unknown and the device was not available for return.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011270181-2020-00049
MDR Report Key9877400
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-25
Date of Report2020-03-25
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-25
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 G1CORPAK MEDSYSTEMS, INC. A DIVISION OF HALYARD HLTH
Manufacturer Street1001 ASBURY DR.
Manufacturer CityBUFFALO GROVE IL 60089
Manufacturer CountryUS
Manufacturer Postal Code60089
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCORTRAK ENTERAL ACCESS SYSTEM
Generic NameDH CORTRAK (EAS)
Product CodeKNT
Date Received2020-03-25
Model Number20-0950
Catalog Number104720102
Lot NumberN/A
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 2020-03-25

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