MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORGRIP NG/NI FEEDING TUBE RETENTION SYSTEM; DH CPK CORGRIP TUBE RETENTION

Model Number	25-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	03/17/2024
Type of Reportable Event	Serious Injury
Additional 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.Root cause could not be determined.All information reasonably known as of 06-may-2024 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, 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.H3 other text : device not returned.
Event or Problem Description
It was reported the patient pulled their 16 french sump tube through a 16 french corgrip clip and had an aspiration event." the reporter "feels that the product works well and that the staff failed to report the tube length after each shift.She felt that this should have been caught by the staff and has requested additional education on the product for their team.".The patient's initial diagnosis was subdural hematoma, stroke, and dementia.The sump tube was placed on or before the (b)(6) and the aspiration event occurred on(b)(6).The user facility notes tubes are typically placed at 65cm and the tube was at 23cm at time of aspiration (with 16 french corgrip still attached).The patient is currently on a ventilator with a tracheostomy tube and a percutaneous endoscopic gastrostomy (peg).The patient is receiving care in a long-term acute care hospitals (ltachs).Additional information received 29-apr-2024 stating "patient had been intubated on admission but had been extubated and doing well." following this event the patient needed immediate re-intubation.

• Brand Name: CORGRIP NG/NI FEEDING TUBE RETENTION SYSTEM
• Common Device Name: DH CPK CORGRIP TUBE RETENTION
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): MEDICAL MURRAY, INC.; 540 capital drive; suite 150; lake zurich IL 60047
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19268076
• Report Number: 3011270181-2024-00053
• Device Sequence Number: 15190721
• Product Code: KNT
• UDI-Device Identifier: 00350770469041
• UDI-Public: 00350770469041
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K133599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 25-016
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 16 FR SUMP TUBE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 67 KG