MAUDE Adverse Event Report: AVANOS MEDICAL INC. DH EF PEG INITIAL PLACEMENT PRODUCTS; MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PULL

Model Number	7180-20
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the digestive health feeding tube (pull peg) was placed by the physician.When the peg was being pulled down the esophagus the physician noticed small tearing and dilation of the esophagus by the internal bumper of the peg tube.The physician indicated that it seemed like the bumper was too stiff.The peg tube was placed in the patient with no other issues.The user noted that ¿for an initial peg tube insertion antibiotics are given prophylactically." there was no reported injury.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation; therefore, a root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of on (b)(6) 2021 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: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Common Device Name: MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PULL
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12991735
• Report Number: 3006646024-2021-00023
• Device Sequence Number: 17480891
• Product Code: KNT
• UDI-Device Identifier: 00350770409795
• UDI-Public: 00350770409795
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/13/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7180-20
• 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: 11/29/2021
• Initial Report FDA Received Date: 12/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown