MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC* GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS - 16 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	8100-16LV
Medical Device Problem Codes	Migration (4003); Unintended Deflation (4061)
Health Effect - Clinical Codes	Death (1802); Peritonitis (2252)
Date of Event	01/18/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
A review of the device history record is in-progress.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 19 feb 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).Device not returned.
Event or Problem Description
Avanos medical inc.Received a single report that referenced four different incidences, which were associated with two separate units, involving the same patient.This is the first of four reports.Refer to 9611594-2021-00025 for the second report.Refer to 9611594-2021-00026 for the third report.Refer to 9611594-2021-00027 for the fourth report.It was reported that the patient developed peritonitis following migration of the feeding tube soon after placement.The tube appeared to be pierced, resulting in deflation of the balloon.The anchors supporting the stoma site also broke.The patient was refused for laparotomy surgery, treated with antibiotics and was transferred to palliative care.The patient then passed away.Per additional information received, the gastrostomy surgery took place on (b)(6) 2021 in the interventional radiology department.There was nothing to report following the procedure.The patient was moved to the visceral surgery department following the procedure.No information was provided on what procedure, if any, occurred there.For the next six days there were no reports on the patient.On (b)(6) 2021, the patient was transferred to palliative care, and then died.It is at this time that the visceral surgery department realized that the balloon of the device had burst and the sutures were no longer in place.Additional information received 09-feb-2021 indicated that the hospital did not attempt to repair or open a new kit after the first suture break.The hospital "noticed (belatedly) that the balloon was defective and all sutures break [broke].Despite this the feeding was maintained and no attempt was made to repair this.The only information we currently have is that during the 48 hours of post operative verification, the balloon was not defective.".
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.Investigation remains in progress.All information reasonably known as of april 7, 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-ehc-21-00130.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
The device history record for lot: 30080899 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The reported incident related to tube migration was not seen in the lab.The entire feeding tube was not missing any component.Root cause could not be determined.All information reasonably known as of 12 may 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).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.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11355230
• Report Number: 9611594-2021-00022
• Device Sequence Number: 19692922
• Product Code: KNT
• UDI-Device Identifier: 00350770442921
• UDI-Public: 00350770442921
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K842076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: 8100-16LV
• Device Catalogue Number: N/A
• Device Lot Number: 30080899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/15/2021; 04/26/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 04/08/2021; 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INITIAL PLACEMENT KIT.
• Outcome Attributed to Adverse Event: Death