MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number 98431

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device history record for lot 20006874 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.A photo of the device was provided by the distributor.The photo confirmed the reported incident; however, root cause could not be determined.All information reasonably known as of 23 sep 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 inc.Complaint database and identified as complaint (b)(4).

Event Description

It was reported that the "button fell off right after the procedure was performed;" the sutures broke.No patient injury was reported.Additional information received 03-sep-2020 indicated that no medical intervention was required; a new kit was opened to perform the replacement.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR
• 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 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10586578
• MDR Text Key: 221806097
• Report Number: 9611594-2020-00187
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984315
• UDI-Public: 00350770984315
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 98431
• Device Catalogue Number: N/A
• Device Lot Number: 20006874
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2019
• 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