MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC PEG KIT, ENFIT, CONNECTORS-20 FR-PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	9640-20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 11-mar-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.
Event or Problem Description
It was reported there were two events of for the first event it was noted "peg outreach attempted to traction pull (b)(6) 2023 would not pull and bumper did not collapse.Had endoscopy on (b)(6) 2024 and gastroenterologist tried to traction pull and not able to, so retrieved endoscopically." the percutaneous endoscopic gastrostomy (peg) tube was initially placed on (b)(4) 2022.The current status of the patient was reported to be stable.No injury occurred to the patient.
Additional Manufacturer Narrative
H6/ investigation findings-no code: use related.The device history record for the reported lot number, 30155096, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The reported device was returned and evaluated.Approximately 2-inches of a used peg (percutaneous endoscopic gastrostomy) tubing with the bumper attached to it was returned.There were no abnormalities observed on the sample.The bumper did not exhibit visible damage and there was no flashing or excess material observed on its surface.The incident information on the accompanying documentation states that the patient had the peg placed on (b)(6) 2022, and the attempt to traction pull was on 12-dec-2023.The peg tube was in the patient for 559-days or approximately 80 weeks (19-months).The event reported was most likely caused by the length of the time the tube was in the patient.The root cause was determined to be ¿user: inappropriate use.¿ all information reasonably known as of 02-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 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: MIC PEG KIT, ENFIT, CONNECTORS-20 FR-PULL
• 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: 18889913
• Report Number: 3006646024-2024-00008
• Device Sequence Number: 18040021
• Product Code: KNT
• UDI-Device Identifier: 00350770446431
• UDI-Public: 00350770446431
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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 Expiration Date: 09/07/2023
• Device Model Number: 9640-20
• Device Catalogue Number: N/A
• Device Lot Number: 30155096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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 Age: 39 YR
• Patient Sex: Female