MAUDE Adverse Event Report: AVANOS MEDICAL INC. LAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22 FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	10237
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	07/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 23-aug-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, inc.Complaint database and identified as complaint (b)(4).The device was not returned.
Event or Problem Description
It was reported the t-fasteners were broken and missing causing the patient peritonitis due to tube migration while being hospitalized for multisystem trauma received from a pedestrian/automobile accident.The patient was the pedestrian involved in the accident.Initial hospitalization required patient admission to the icu for treatment and intubation to maintain airway.On (b)(6) 2021 the patient's feeding tube was placed using an introducer kit.The "correct" tube placement was confirmed via esophagogastroduodenoscopy (egd) visualization.On (b)(6) 2021 the patient returned to the operating room (or) for an emergency exploratory lap due to worsening condition.During the procedure it was discovered that two t-fasteners were broken and two t-fasteners were missing causing the tube to migrate.Three liters of enteral feeding solution was removed from the patient's abdominal cavity.The patient currently remains intubated and in stable but critical condition in the intensive care unit (icu) for treatment of multisystem trauma caused by pedestrian/automobile accident, further complicated by the diagnosis of peritonitis.The patient's peritonitis is being treated with intravenous (iv) antibiotics.The user reports a medsun report was filed on 29-jul-2021, but the medsun report number was not provided.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30063819, 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 28-sep-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, 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: LAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22 FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12360338
• Report Number: 9611594-2021-00111
• Device Sequence Number: 14405871
• Product Code: KGC
• UDI-Device Identifier: 00350770102375
• UDI-Public: 00350770102375
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• 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 faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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 Expiration Date: 04/22/2022
• Device Model Number: 10237
• Device Catalogue Number: N/A
• Device Lot Number: 30063819
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR