MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	9640-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has been returned and the investigation remains in progress at this time.A review of the device history record is in-progress.All information reasonably known as of 23 feb 2023 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.Device evaluation anticipated but not begun.
Event or Problem Description
It was reported that the peg (percutaneous endoscopic gastrostomy) tube was placed on (b)(6) 2022 and the pull method was used.The patient sustained an esophageal tear after pulling the peg tube through.Surgery was required for esophageal repair.The peg tube in-use for 58 days and was removed on (b)(6) 2023.The patient's status was reported to be in home care without ventilation or oxygen requirements.Per additional information received on 06feb2023, the patient was transferred to icu (intensive care unit) post oesophageal repair and was on antibiotics and pain relief.The patient is home and healed well.
Additional Manufacturer Narrative
The device history record for lot 30192274 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The returned sample was photographed upon receipt to look for any potential abnormalities like hardened material around the tubing prior to decontamination, no visible crusty, hardened material seen.After the decontamination process, the sample was examined and inspected.There were no identified burrs, sharp edges, and flashing that could tear any surface.Based on sample evaluation, the incident could not be confirmed, and a root cause could not be identified.All information reasonably known as of 03 apr 2023 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.

• Brand Name: MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16432354
• Report Number: 3006646024-2023-00011
• Device Sequence Number: 5297494
• Product Code: KNT
• UDI-Device Identifier: 00350770446448
• UDI-Public: 00350770446448
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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 Expiration Date: 04/11/2024
• Device Model Number: 9640-14
• Device Catalogue Number: N/A
• Device Lot Number: 30192274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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: ANTIBIOTICS AND PAIN RELIEF; PEG TUBE REMOVAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 3 KG