MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98434
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30027185 was reviewed and the product was produced according to product specifications.All information reasonably known as of 25 aug 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.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).
Event or Problem Description
It was reported that during the procedure, the dilator broke.The broken piece was retrieved from the patient using jaw forceps, and there was no injury to the patient.Per additional information received 7 aug 2020, the distal end of the dilator had broken, leaving a 1.5 inch section in the patient.The procedure was able to be completed with the broken dilator.No further information provided.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10453673
• Report Number: 9611594-2020-00165
• Device Sequence Number: 14524094
• Product Code: KGC
• UDI-Device Identifier: 00350770984346
• UDI-Public: 00350770984346
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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 Expiration Date: 10/01/2021
• Device Model Number: 98434
• Device Catalogue Number: N/A
• Device Lot Number: 30027185
• 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: 08/06/2020
• Initial Report FDA Received Date: 08/26/2020
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 83