MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTROSTOMY FEEDING TUBE, 22 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	0100-22
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 19-sep-2018 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.(b)(4).
Event or Problem Description
A user facility report (b)(4) was received that stated: patient underwent a surgical procedure earlier this month to place a gastrostomy tube.Balloon on device was successfully tested prior to inserting into patient.The device was inserted by the surgeon and the balloon was inflated once in the patient and was noted to be successfully inflated.Patient became unstable overnight and had a ct pulmonary angiography (ctpa) in the morning the next day.Patient had a pulmonary embolus and also noted to have a large amount of intraperitoneal free air.The patient was taken quickly back to the qr to assess the abdomen.When the patient was transferred off the bed, the gastronomy tube fell out of the patient and the balloon was deflated.The patient was noted to have tube feeding in the abdomen.The patient required an icu admission following surgery.".
Additional Manufacturer Narrative
The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 20-nov-2018 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).

• Brand Name: MIC GASTROSTOMY FEEDING TUBE, 22 FR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7895209
• Report Number: 9611594-2018-03640
• Device Sequence Number: 11189224
• Product Code: KNT
• UDI-Device Identifier: 10680651947823
• UDI-Public: 10680651947823
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K842076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: 03/01/2021
• Device Model Number: 0100-22
• Device Catalogue Number: 991094782
• Device Lot Number: AA8071D10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/20/2018
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 78