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

Model Number 98705

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2021

Event Type  malfunction  

Event 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.

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).

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
• Type of Device: 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
• MDR Text Key: 281336625
• Report Number: 9611594-2021-00158
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770987057
• UDI-Public: 00350770987057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093312
• 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
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 68 KG