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

Model Number	8160-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
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 (b)(6) 2020 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.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).B)(4).
Event or Problem Description
An report was received via fda medwatch / fda user facility report # (b)(4) and the following information was provided: from staff- patient presented to outpatient gastroenterology office for a percutaneous endoscopic gastrostomy (peg) tube removal.Upon attempt of removal, the internal bumper failed to come out of the peg.Provider ordered a stat x-ray of the abdomen.Provider discussed with the radiologist and confirmed the peg tube bumper is in the stomach, 2.9 cm foreign body in the stomach lumen.From gastroenterologist's office note removal of the peg tube was attempted in the office traction technique was used the internal bumper failed to come out with the feeding tube stat x-ray of the abdomen, lateral and ap was ordered discussion with radiologist revealed the peg tube bumper is in the stomach, 2.9 cm foreign body in the stomach lumen patient has been transported to endoscopy department for foreign body removal with esophagogastroduodenoscopy (egd) today patient also verbalized understanding of current medical situation and the need to have and egd today for removal of the internal bumper.Patient was transported to the endoscopy department for foreign body removal with egd patient refused removal of foreign body as well as admission stay and was discharged home.Original intended procedure: removal of peg tube.Device failed (eg broke, couldn't get it to work or stopped working).Additional information for patient #1: other information about the patient that may have influenced the outcome of the event please note the device information provided is not the exact device information as we were not able to retrieve that the information provided was for another device we have similar to the one that broke.Event date time frame: (b)(6) 2020.
Additional Manufacturer Narrative
The device history record for the reported lot number, 20016182, 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 04-jun-2020 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
All information reasonably known as of 24-apr-2020 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 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 20 FR
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9950395
• Report Number: 3006646024-2020-00010
• Device Sequence Number: 14311586
• Product Code: KNT
• UDI-Device Identifier: 00350770446103
• UDI-Public: 00350770446103
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2020

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: 05/31/2021
• Device Model Number: 8160-20
• Device Catalogue Number: 104461000
• Device Lot Number: 20016182
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/16/2020; 05/12/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 04/24/2020; 06/04/2020
• 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: Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 84