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

Model Number	8180-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the physician was in the intensive care unit (icu) performing a peg (percutaneous endoscopic gastrostomy) procedure and had issue with the trocar (safety needle).Lodged in the abdominal wall and when attempting to retrieve it, the tip of the trocar broke off.Patient required surgery to retrieve the broken tip." additional information received 04-jan-2024 stating the clinicians "performed an exploratory laparotomy, partial colectomy, repair of small bowel, omentectomy, colostomy creation, ventral hernia repair, wound exploration and foreign body removal, gastrostomy tube placement.".
Additional Manufacturer Narrative
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.Root cause could not be determined.All information reasonably known as of 11-jan-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.H3 other text : device not returned.

• Brand Name: MIC SAFETY 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18510896
• Report Number: 3006646024-2024-00003
• Device Sequence Number: 3533863
• Product Code: KNT
• UDI-Device Identifier: 00350770445991
• UDI-Public: 00350770445991
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/15/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female