MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	7180-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional 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.Root cause could not be determined.All information reasonably known as of (b)(6) 2020 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 halyard health represents all of the known information at this time.Halyard health 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).Mw 5093201.
Event or Problem Description
Avanos medical, inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the second of three reports.Refer to 3006646024-2020-00007 for the first event.Refer to 3006646024-2020-00009 for the third event.Additional information received 12-mar-2020 stated: there were at least 2 instances where a bumper separated from the tube.Neither patient had an unusual body habits in the sense that i did not expect the issue was related to abdominal obesity.The initial complaint was referenced as it was reported via fda medwatch / fda user facility report # mw 5093201 received on (b)(6) 2020, and the following information was provided: halyard g tube which was almost 2 yrs old and was supposed to be removable by external traction, broke upon removal attempt, leaving the internal bumper inside the stomach.Urgent ego was required to remove the internal bumper from the stomach.Bumper was felt to too large to be allowed to pass spontaneously significant concern for small bowel obstruction requiring laparotomy.If bumper passed beyond stomach due to peristalsis therefore was significant urgency for endoscopy.Egd revealed separated internal bumper in stomach see above.Unfortunately, this is the most dramatic incident related tog tube at my facility.But i have seen several g tubes of this brand recently that were degraded way beyond what their calendar age would indicate.I have pre-emptively performed endoscopy to remove them instead of going through what i went through with the pt described above.I feel pts are having to undergo unnecessary endoscopic procedures.The median age of these prematurely degraded g tubes is around 4 months.I am aware of mfr recs stating that tubes more than few months old may exhibit this phenomenon; however, i have been working with g tubes for almost 20 yrs and have not see this level of degradation.Materials issues fda safety report id# (b)(4).The tube in question was 360 days old.

• Brand Name: MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PULL
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9927115
• Report Number: 3006646024-2020-00008
• Device Sequence Number: 2827497
• Product Code: KNT
• UDI-Device Identifier: 00350770409795
• UDI-Public: 00350770409795
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2020

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: 7180-20
• Device Catalogue Number: 104097902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/05/2020
• Patient Sequence Number: 1