MAUDE Adverse Event Report: AVANOS MEDICAL INC. ENTERAL DEVICE DECLOGGING SYSTEM; DH CPK CLOG ZAPPER ACCESSORIES

Model Number	20-0002
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0008034165 was reviewed and the product was produced according to product specifications.All information reasonably known as of 19 feb 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Complaint database and identified as complaint (b)(4).(b)(4).
Event or Problem Description
Fda medwatch / fda user facility report #: (b)(4) received on 31-jan-2020, and the following information was provided: "patient had a clogged peg feeding tube, clog zapper enteral feeding tube declogging system obtained to attempt to declog the ng [nasogastric] tube.Instructions followed by rn [registered nurse] to instill declotting liquid with applicator and plastic tube.When plastic tube removed it broke leaving 6 inches of plastic tubing.Patient went to ir [interventional radiology] to have peg tube removed and replaced, plastic tubing could not be located." "device failed (e g broke, couldn't get it to work or stopped working)." additional information received 03-feb-2020 indicated the patient is stable.
Additional Manufacturer Narrative
Additional information provided for b3: date of event.All information reasonably known as of 22 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: ENTERAL DEVICE DECLOGGING SYSTEM
• Common Device Name: DH CPK CLOG ZAPPER ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9734883
• Report Number: 3006646024-2020-00003
• Device Sequence Number: 2352538
• Product Code: KNT
• UDI-Device Identifier: 10680651456097
• UDI-Public: 10680651456097
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K970178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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 Expiration Date: 10/08/2020
• Device Model Number: 20-0002
• Device Catalogue Number: 104560900
• Device Lot Number: 0008034165
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1
• Patient Age: 80 YR