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

Model Number	7150-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2020
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.All information reasonably known as of 22-jul-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 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, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported, "during attempted replacement of bumper peg.While doing traction removal of the existing tube (originally placed on (b)(6) 2019) the tube fractured during attempted traction removal and the remainder is still inside the patient." the physician stated the patient was at another facility and was being monitored.The physician stated the patient had not exhibited any symptoms and the fractured part of the tube was still inside the patient, as far as he knew.Additional information received 06-jul-2020 stated the mushroom (flange) part of the tube remained inside the gastrointestinal (gi) tract.The physician tried to refer the patient for endoscopic removal, but the accepting facility declined to perform endoscopy opting instead for serial x-ray examinations.The initial post procedure x-ray showed the remnant of the tube inside the patient's stomach.The remnant had not been extracted.A foley type 20-french tube was placed in the stoma.

• Brand Name: MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PUSH OTW
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10314905
• Report Number: 3006646024-2020-00029
• Device Sequence Number: 14255377
• Product Code: KNT
• UDI-Device Identifier: 00350770409764
• UDI-Public: 00350770409764
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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: 7150-20
• Device Catalogue Number: UNKNOWN
• 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: 07/02/2020
• Initial Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 54