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

Model Number 10237

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 13-dec-2019 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.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

Avanos medical, inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the third of three reports.Refer to 9611594-2019-00250 for the first event.Refer to 9611594-2019-00251 for the second event.It was reported the trans abdominal bolsters are falling off causing the feeding tube to become dislodged and leak.There was no reported patient injury.Additional information received 21-nov-2019 stated that some have fallen off with-in days of insertion.The physician notes there have been least three incidences of the bolsters falling off prior to the 2-week.No additional information was provided.

• Brand Name: LAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22 FR 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: 9470307
• MDR Text Key: 196953690
• Report Number: 9611594-2019-00252
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770102375
• UDI-Public: 00350770102375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10237
• Device Catalogue Number: 10237-04
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1