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	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is in-progress.All information reasonably known as of 14 jul 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).Device not returned.
Event or Problem Description
It was reported that "patient had peg insertion done by the endoscopist.Failed on the original site, so left the introducer needle catheter.Then later went and tried on the other side.After the peg insertion, failed to retrieve the catheter from the initial original site.No harm to the patient." clinician later removed the sheath on post-operative day two.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
Corrected data: d4 expiration date, h4.The device history record for lot 0002994170 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Based on the results of the investigation and information provided by the account, the root cause of the reported event is incorrect use.All information reasonably known as of 26 aug 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: 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: 10273099
• Report Number: 3006646024-2020-00026
• Device Sequence Number: 825250
• Product Code: KNT
• UDI-Device Identifier: 10350770462070
• UDI-Public: 10350770462070
• 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): 08/28/2020

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: UNKNOWN
• Device Lot Number: 0002994170
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/28/2020
• Patient Sequence Number: 1