MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR JEJUNAL/GASTRIC FEEDING TUBE, 22FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number 98438

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30017257 was reviewed and the product was produced according to product specifications.All information reasonably known as of 1 may 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 Description

Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the first of two reports.Refer to 9611594-2020-00075 for the second report.It was reported that the smallest barrel on the dilator came off during use, and fell into the patient's stomach.There was no injury to the patient reported.Per further clarification received on 8 apr 2020, the first dilator was in use when the smallest barrel of the dilator came off into the patient's stomach.That dilator was disposed of and a second dilator opened.Per additional information received 9 apr 2020, there was no medical intervention required.The user of the kit was "very familiar" with the use of the dilator.No further information has been provided at this time.

Manufacturer Narrative

Correction: the product code had been reported incorrectly in the initial report.D1 and d4 have been updated.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 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).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: INTRODUCER KIT FOR JEJUNAL/GASTRIC FEEDING TUBE, 22FR DILATOR
• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10019064
• MDR Text Key: 189704001
• Report Number: 9611594-2020-00074
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984308
• UDI-Public: 00350770984308
• Combination Product (y/n): N
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 98438
• Device Catalogue Number: N/A
• Device Lot Number: 30017257
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 05/26/2020
• Patient Sequence Number: 1