MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ENFIT CONNECTOR; DH CPK NG TUBES

Model Number 40-1362

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Type  Injury  

Event Description

Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different patients.This is the first of four reports.Refer to 9611594-2022-00023 for the second report, refer to 9611594-2022-00024 for the third report and refer to 9611594-2022-00025 for the fourth report.It was reported a perforation occurred, with the corflo bolus feed ng tube.The event occurred while the patient was in the intensive care unit (icu).Additional information received on 01-feb-2022 reported that there was a perforation and there was no medical intervention.Additional information received 17-feb-2022, reported that the trauma surgical intensive care unit (tsicu) registered nurse (rn), of 9 years made a single attempt [to insert the tube] that resulted in a naso/oropharynx perforation.The patient reportedly was alert and oriented and denied any pain with the placement of the soft ng tube.The patient¿s current condition is unknown.

Manufacturer Narrative

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.All information reasonably known as of 28-feb-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.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 complaint database and identified as complaint (b)(4).

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ENFIT CONNECTOR
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13625617
• MDR Text Key: 286527353
• Report Number: 9611594-2022-00022
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770459974
• UDI-Public: 00350770459974
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 40-1362
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female