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

Model Number 50-4016E1

Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2019

Event Type  malfunction  

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 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 second of three reports.Refer to 3006646024-2019-00024 for the first report.Refer to 3006646024-2019-00026 for the third 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.

Manufacturer Narrative

One used sample was returned for evaluation.There was a jagged breaking between the two bonded components.The previously bonding components were inspected and the bond were still intact and secured even if a breaking had occurred.The area where the two bonded components were inspected.The distal side had an opening as expected.The proximal side exhibited clogging with no openings noticed.The complaint is confirmed and the root cause is determined to be manufacturing related.All information reasonably known as of 13 dec 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).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
• Type of Device: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9238980
• MDR Text Key: 190765617
• Report Number: 3006646024-2019-00025
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10815149021826
• UDI-Public: 10815149021826
• Combination Product (y/n): N
• PMA/PMN Number: K882867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2022
• Device Model Number: 50-4016E1
• Device Catalogue Number: 104618700
• Device Lot Number: 0203172166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2019
• Removal/Correction Number: Z NUMBER PENDING
• Patient Sequence Number: 1