MAUDE Adverse Event Report: AVANOS MEDICAL INC. ENTERAL ACCESS DILATION SYSTEM; DH EF PERC PLACEMENT PRODUCTS

Model Number	98705
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a piece of a telescoping dilator broke off inside of a patient.Additional information received 14-oct-2021 stated the physician "noticed when pulling the dilators back out, it was difficult and the innermost one did not catch on the second one as it should have and the second one advanced into the patient.Upon removal of the dilators, the physician could barely see the one that was in the stomach, attempted to remove it via snare (was unsuccessful).The g-tube was placed and the patient went to the gi (gastro intestinal) lab to have this foreign body removed." the broken piece was removed via endoscopy on (b)(6) 2021.The patient was doing well, no complications.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 08-nov-2021 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, inc.Complaint database and identified as complaint (b)(4).
Additional Manufacturer Narrative
The device history record for the reported lot number, 30136520, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample dilator was received with the original pouch packaging and the packaging was opened.The device was evaluated and a separation of the tube was not observed; furthermore, there was no unusual breakage noted.No device problem was found and no problem was detected.The root cause could not be determined.All information reasonably known as of 28-dec-2021 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, inc.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: ENTERAL ACCESS DILATION SYSTEM
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12781609
• Report Number: 9611594-2021-00158
• Device Sequence Number: 14958777
• Product Code: KGC
• UDI-Device Identifier: 00350770987057
• UDI-Public: 00350770987057
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K093312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 05/26/2023
• Device Model Number: 98705
• Device Catalogue Number: N/A
• Device Lot Number: 30136520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 68 KG