MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO PEG KIT WITH ENFIT CONNECTOR; DH CPK PEG INITIAL PLACEMENT PRODUCTS

Model Number	50-6016E1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 0203201715 was reviewed and the product was produced according to product specifications.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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that after a peg tube was placed (at a different hospital), the nurse attempted to remove via traction, but the tube snapped, leaving the bumper inside the patient.Surgery was required to remove the bumper from the old stoma tract.Per additional information received 02 mar 2020, the patient underwent surgery to remove peg fragments that were retained in stoma.The patient was admitted to the hospital for this surgery from (b)(6) 2020 through (b)(6) 2020, and then was readmitted from (b)(6) 2020 through (b)(6) 2020.The surgical team inserted a foley catheter into the stoma site, and reported that it must stay in place for three weeks, starting (b)(6) 2020.The patient will have the foley catheter removed on (b)(6) 2020, along with possible surgical closure of the stoma.The patient is currently medically improving but still complaining of pain in the stoma area.The patient is also receiving treatment for concurrent prostatitus.No further information has been provided at this time.
Additional Manufacturer Narrative
The device history record for lot 0203201715 was reviewed and the product was produced according to product specifications.All information reasonably known as of 14 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 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: CORFLO PEG KIT WITH ENFIT CONNECTOR
• Common Device Name: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9817326
• Report Number: 3006646024-2020-00006
• Device Sequence Number: 1300143
• Product Code: KNT
• UDI-Device Identifier: 10815149021765
• UDI-Public: 10815149021765
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 05/31/2022
• Device Model Number: 50-6016E1
• Device Catalogue Number: N/A
• Device Lot Number: 0203201715
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1
• Patient Age: 61 YR