MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTROSTOMY FEEDING TUBE, ENFIT CONCTR, 18 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	8100-18
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the "nurse was providing medications and [patient] heard 'loud pop' and tube started to come out.Transferred to ir (interventional radiology) and balloon was ruptured." there was no reported injury.Additional information received (b)(6) 2023 stated "the patient had an upper gi (gastrointestinal) bleed from her gastric remnant where the gastrostomy tube was entering the stomach.Ir was unable to embolize the bleed.Patient (receiving anticoagulant therapy at home) admitted to hospital (b)(6) 2023 due to home care nurse reporting blood-soaked dressing around feeding tube site.The patient experienced dizziness status post partial gastrectomy, open splenectomy, trans hiatal esophagectomy with cervical esophagostomy due to recent hospitalization for a gi bleed.While patient was the in the er (emergency room) the rn (registered nurse) was administering medications through the balloon inflation port of the feeding tube when she heard a "loud pop" and "the tube started to come out".After the loud pop was heard, the patient taken to ct (computed tomography) for a cat scan of the abdomen.The cat scan revealed "an active arterial bleed around gastrostomy balloon insertion site." on (b)(6) 2023 the patient was taken to ir and feeding tube was replaced.Ir was unable to embolize the arterial bleed at the time of tube placement.An angiogram was performed (b)(6) 2023 and the arterial bleed was successfully stopped at that time.The patient was initially admitted to the icu (intensive care unit).As of (b)(6) 2023 the patient is currently in "stable but serious" condition on the medical surgical floor.
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 not possible as no lot number was provided.All information reasonably known as of (b)(6) 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 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.
Additional Manufacturer Narrative
Correction d4: lot number confirmed.H6/investigation findings/code not available: user : inappropriate use the device history record for the reported lot number, 30226672, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The device was evaluated the "sample provided was evaluated and balloon burst was confirmed.However, based on the customer comments and details added in product information section related to "complaint received 29-mar-2023 and a follow up call with company representative reporting: a misconnect incident.Nurse attempting to administered medications to patient via the balloon inflation port." this event seems to be a misused related incident.Per instructions for use (ifu) related to balloon maintenance stated the following: refill the balloon using sterile or distilled water, not air or saline.Saline can crystallize and clog the balloon valve or lumen, and air may seep out and cause the balloon to collapse.The root cause was inappropriate use.All information reasonably known as of 18-may-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 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 GASTROSTOMY FEEDING TUBE, ENFIT CONCTR, 18 FR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV (AVENT 2); avenida el castillo 17-b; nogales, sonora
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16799480
• Report Number: 9611594-2023-00056
• Device Sequence Number: 3237591
• Product Code: KNT
• UDI-Device Identifier: 00350770442938
• UDI-Public: 00350770442938
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K842076
• 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
• Report Date (Section B): 05/18/2023

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: 03/23/2024
• Device Model Number: 8100-18
• Device Catalogue Number: N/A
• Device Lot Number: 30226672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 72 KG