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

Model Number	8180-20
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 03-apr-2025 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 the "patient underwent scheduled outpatient egd (esophagogastroduodenoscopy) with g-tube (gastrostomy tube) placement.During the g-tube insertion, the clear plastic catheter slowly began disappearing into the patient's subcutaneous adipose tissue.[the clinical team] lost endoscopic visualization.Fortunately, it was quickly retrieved with a kelly clamp by the gi (gastrointestinal) fellow.The g-tube was able to be placed.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30292018, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 27-aug-2025 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 (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
Additional information was received on 19-jun2025 from medwatch/ fda user facility report mw report mw5167427 and the following was reported: patient underwent scheduled outpatient egd(esophagogastroduodenoscopy) with g tube placement.During the g tube insertion, the clear plastic catheter slowly began disappearing into the patient's subcutaneous adipose tissue.We lost endoscopic visualization.Fortunately, it was quickly retrieved with a kelly clamp by the gi fellow.The g tube was able to be placed.Upon discussion with the gi attending after the case, there may be a design flaw in this product.The end of the trocar catheter is not tapered, which essentially would prevent this from happening.Also, the catheter is short, which contributed to this close call.A longer catheter would be safer for patients with more subcutaneous adipose tissue.Upon reflection, we had another case approximately 1.5 years ago where the catheter was lost and the patient needed to have it surgically removed.It was the same product, but staff attributed it to a probable fistula.Thankfully, the outcome from this case was not similar.
Additional Manufacturer Narrative
Additional infromation: a2, a3a, a4 and b5.All information reasonably known as of 18-jul-2025 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 comp (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 SAFETY PE PEG KIT WITH 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: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21763079
• Report Number: 3006646024-2025-00010
• Device Sequence Number: 18258614
• Product Code: KNT
• UDI-Device Identifier: 00350770445991
• UDI-Public: (01)00350770445991(240)120007247(17)250430(10)30292018
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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: 04/30/2025
• Device Model Number: 8180-20
• Device Catalogue Number: 8180-20
• Device Lot Number: 30292018
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 07/29/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/18/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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: KELLY CLAMP
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 109 KG