MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETY PEG KIT - PULL METHOD; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	8180-20
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Difficult to Remove (1528)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical inc.Received a single report that referenced different incidences, which were associated with separate units, involving different patients.This is the third of three reports.Refer to 3006646024-2024-00013 for the first report.Refer to 3006646024-2024-00014 for the second report.It was reported, ¿several of the doctors have had issues with the bumper (piece that holds the tube inside the stomach).When they need to do a peg exchange, or just remove the peg, normally they should be able to pull it out of their stomach, from the outside of their body without a scope.However, there have been issues lately pulling it out.So instead, we can do a scope, and cut the tube from the outside, grab around the bumper from inside the stomach with a scope, and pull what is left back through the mouth." per additional information received on 22-mar-2024, ¿there have been no patient deaths, but we have had patients experience some irritation in their esophagus and mild tearing from trying to pull the bumper out.¿.
Additional Manufacturer Narrative
H6: component codes: 4756 appropriate term/code not available: bumper 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.A root cause could not be determined.All information reasonably known as of 08 apr 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 reported event but is relaying the information 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).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.

• Brand Name: MIC SAFETY PEG KIT - PULL METHOD
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson AZ 85756
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19078013
• Report Number: 3006646024-2024-00015
• Device Sequence Number: 14960050
• Product Code: KNT
• UDI-Device Identifier: 00350770445991
• UDI-Public: 00350770445991
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• 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): 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8180-20
• 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: 03/15/2024
• Initial Report FDA Received Date: 04/10/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown