MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETY PEG KIT - PULL METHOD; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	7180-20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that the customer was "unable to remove the peg in clinic percutaneously with 2 attempts." the patient was required to have an egd [esophagogastroduodenoscopy].Additional information received on 30-dec-2019 indicated the peg tube was in place for 5 months (b)(6) 2019 to (b)(6) 2019).The person removing the peg tube had 25 years experience working in gastroenterology.The patient had the peg endoscopically removed on (b)(6) 2019.
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The actual complaint product was returned for evaluation.One used sample was received without product packaging.The sample does not contain a lot number identification.The failure reported was not confirmed; the sample only appeared to show signs of ordinary use.The root cause was not identified.All information reasonably known as of 03 mar 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 SAFETY PEG KIT - PULL METHOD
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9568499
• Report Number: 3006646024-2020-00001
• Device Sequence Number: 3170977
• Product Code: KNT
• UDI-Device Identifier: 00350770409795
• UDI-Public: 00350770409795
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7180-20
• Device Catalogue Number: 104097902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 54