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

Model Number 8180-20

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Date 11/11/2022

Event Type  Injury  

Event Description

It was reported, during a pull peg (percutaneous endoscopic gastrostomy) placement, the patient experienced a laceration of the esophagus (when pulling the tube through the esophagus).The physician used a clamp to close the laceration; the patient was eventually discharged from the hospital additional information received 15 nov 2022 reported, the laceration was created when the internal bumper of the tube was pulled through the esophagus; the doctor used a clamp to close it.The patient was discharged on (b)(6) 2022.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 07 dec 2022 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.Device not returned.

Manufacturer Narrative

Manufacturing site updated; a new report will be submitted under mw 3006646024-2022-00003; no further information concerning this reported event will be submitted in mw 2026095-2022-00135.All information reasonably known as of 27 jan 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 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.

Manufacturer Narrative

The new initial report was submitted under mw 3006646024-2023-00003, not under 3006646024-2022-00003, as was previously reported.All information reasonably known as of 03 feb 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 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 comp(b)(6).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: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Type of Device: MIC SAFETY PEG KIT - PULL METHOD
• 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: 15946805
• MDR Text Key: 305144004
• Report Number: 2026095-2022-00135
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10350770445998
• UDI-Public: 00350770445991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8180-20
• Device Lot Number: 30189396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 95 YR
• Patient Sex: Female
• Patient Weight: 41 KG