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

Model Number 25-010

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

It was reported "the magnet disconnected from the probe while placing the corgrip.The patient needed further assistance from the ent [ear, nose and throat] physician to remove the magnet from the nasal cavity." there was no reported injury.Additional information received (b)(6)2022 stated ent was consulted and the ent spent 3-hours at the bedside trying to retrieve the magnet and "may have caused some trauma." there were no reports of adverse effects related to the removal procedure.

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 (b)(6)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, 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.

Manufacturer Narrative

All information reasonably known as of 23-sep-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, 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.

• Brand Name: CORGRIP NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM
• Type of Device: 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 15245775
• MDR Text Key: 304840551
• Report Number: 3011270181-2022-00062
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770458366
• UDI-Public: 00350770458366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162110
• 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,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-010
• 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: 09/19/2022
• 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