MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO SAFETY PEG KIT - PULL METHOD; DH CPK PEG INITIAL PLACEMENT PRODUCTS

Model Number	50-6016
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.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.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 halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
It was reported that the device "displaced without internal bumper.Internal bumper therefore retained." additional information received indicated no injuries reported, but medical intervention was required to obtain part of the device.Required tube replacement.Further additional information has been requested but not yet received.
Event or Problem Description
It was discovered on 30-sep-2019 that 3006646024-2019-00015 is a duplicate of this reported event.From that report, "it was reported that there was a displacement of the peg tube with the internal bumper missing.A new balloon gastrostomy tube was inserted.Patient advised that bumper should pass through bowel movements, but to report to a&e should he experience symptoms of obstruction.".
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.One used sample was received without product packaging.The product does not contain a lot number identification.Branding is visible as "corpak yellow." the tubing is discolored, being darker at the distal end.The bumper is not attached and was not returned.The distal end was examined under magnification; there are jagged remnants of the bumper cover on the outer surface of the tubing.Tubing does not exhibit tears or cuts.The root cause is unknown.All information reasonably known as of 09 oct 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 halyard health 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 SAFETY PEG KIT - PULL METHOD
• Common Device Name: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8922157
• Report Number: 3006646024-2019-00014
• Device Sequence Number: 253669
• Product Code: KNT
• UDI-Device Identifier: 20815149021557
• UDI-Public: 20815149021557
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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 Model Number: 50-6016
• Device Catalogue Number: 104620501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1
• Patient Age: 60 YR