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

Model Number	50-6016E1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Distress (2329); Hematemesis (4478)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
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 in-progress.All information reasonably known as of (b)(6) 2023, 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 reported event but is relaying the information 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.H3 other text : device not returned.
Event or Problem Description
It was reported, that during pull through of the percutaneous endoscopic gastrostomy (peg) tube, the loop wire on the peg snapped, causing the bumper to become stuck in the back of the throat.The tube had to be retrieved using a gastroscope and snare.The procedure was restarted from the beginning.Medical treatment included additional sedation and increased suctioning as the patient became distressed.The next day, the patient vomited coffee ground emesis.The patient was reported to be stable but feeding stopped.Per additional information received on (b)(6) 2023, the patient is clinically stable, and there is no further bleeding.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.Sample evaluation showed the end loop of the percutaneous endoscopic gastrostomy (peg) tube was separated.Under magnification (20x), sliver wiring appeared to be separating from the clear sheath or casing.The sponge bumper appeared to be damaged-free.The bumper was still intact into the tube.The incident was confirmed as reported.A root cause could not be determined.All information reasonably known as of 01 aug 2023 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 reported event but is relaying the information 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.
Additional Manufacturer Narrative
The device history record for lot 30202085 was reviewed and the product was produced according to product specifications.The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 27 jun 2023 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 reported event but is relaying the information 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 STANDARD 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
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16906338
• Report Number: 2026095-2023-00057
• Device Sequence Number: 20542564
• Product Code: KNT
• UDI-Device Identifier: 00350770462073
• UDI-Public: 00350770462073
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2025
• Device Model Number: 50-6016E1
• Device Catalogue Number: N/A
• Device Lot Number: 30202085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/14/2023; 07/19/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/30/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 77 KG