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

Model Number	50-4016E1
Medical Device Problem Codes	Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field action was initiated on (b)(6) 2019 (product recall notice was sent to all potentially impacted customers).The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of (b)(6) 2019 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).Device not returned.
Event or Problem Description
Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving the same patient.This is the third of three reports.Refer to 3006646024-2019-00024 for the first report.Refer to 3006646024-2019-00025 for the second report.It was reported that the hospital has had problems with the placement kits where there was a blockage or the tip of the dilator seemed too narrow for the guidewire.Three kits failed consecutively during a procedure and resulted in a peri-procedural delay due to low stock.No further information provided.

• 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: 9238985
• Report Number: 3006646024-2019-00026
• Device Sequence Number: 1564878
• Product Code: KNT
• UDI-Device Identifier: 10815149021826
• UDI-Public: 10815149021826
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 50-4016E1
• Device Catalogue Number: 104618700
• Device Lot Number: 0203172166
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/25/2019
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z NUMBER PENDING
• Patient Sequence Number: 1