MAUDE Adverse Event Report: AVANOS MEDICAL INC. FARRELL VALVE CLOSED ENTERAL DECOMPRESSION SYSTEM; DH CPK FARRELL BAG

Model Number	20-4100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2018
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 07-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).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.Device not returned.
Event or Problem Description
It was reported that farrell adapter pieces were found while manually venting patient.Additional information received on 29-oct-2018 stated that aside from using the farrell bag, the stomach is vented manually with a 60 ml syringe.During venting, the patient's father found 3 small pieces of orange plastic in the syringe.The bag was discarded and the father did not actually see a broken adapter or that pieces were missing from the adapter.There was no patient injury nor intervention required.
Additional Manufacturer Narrative
The device history record for the lot number involved 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 05-feb-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).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: FARRELL VALVE CLOSED ENTERAL DECOMPRESSION SYSTEM
• Common Device Name: DH CPK FARRELL BAG
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8062001
• Report Number: 3011270181-2018-00045
• Device Sequence Number: 19368612
• Product Code: KNT
• UDI-Device Identifier: 10680651457353
• UDI-Public: 10680651457353
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K853253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2019

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: Lay User/Patient
• Device Model Number: 20-4100
• Device Catalogue Number: 104573500
• Device Lot Number: SC187302
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 01/26/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 02/05/2019
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 64