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

Model Number 8180-20

Device Problems Difficult to Fold, Unfold or Collapse (1254); Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported, the percutaneous endoscopic gastrostomy (peg) tube was unable to be removed by traction removal despite using proper technique.The peg had to be removed via endoscopy through the patient mouth.There was no injury reported.Endoscopy report noted: ¿stomach: the traction-removable peg was identified in the stomach body.The bumper was freely mobile and not [buried].We initially attempted traction removal under endoscopic visualization.The bumper is somewhat broader than other traction removable bumpers and more elastic.As such, once the bumper collapsed as it was passing into the peg tract, it would spring back into the gastric body, preventing removal.We then decided to remove the bumper through the mouth.We secured the bumper with a roth net, then cut the peg tubing about 5 cm from the skin.We were then able to remove the peg through the mouth.Duodenum: the duodenal mucosa showed no abnormalities in the entire duodenum.The gastroscope was the slowly withdrawn and removed.¿.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.The root cause is unknown.All information reasonably known as of 21 dec 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.

Manufacturer Narrative

H6: component code: 4756 appropriate term/code not available: bumper.All information reasonably known as of 09 apr 2024 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.

Manufacturer Narrative

All information reasonably known as of (b)(6) 2024 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: MIC SAFETY PEG KIT - PULL METHOD
• Type of Device: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson 85756
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18372139
• MDR Text Key: 331186725
• Report Number: 3006646024-2023-00037
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770445991
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8180-20
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• 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 Sex: Male