MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN JEJUNOSTOMY TUBE; DH EF BALLOON TUBES PRODUCTS

Model Number UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011)

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 16-mar-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.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, "the enfit adapters for hooking the tubes up to gravity drainage have a drastic narrowing to the lumen that significantly decreases the decompressing capability of the tube.Just this week we had a patient with this tube that ended up with aspiration pneumonia in part due to inadequate decompression and drainage." additional information received 24-feb-2020 stated the physician feels the issue is with the enfit gastrostomy port being to narrow to allow adequate decompression.To overcome this issue the physician is cutting off the gastrostomy port enfit connector.The physical then uses a foley catheter bag with a legacy "christmas tree" adaptor to connect to the gastrostomy portion of the gastrostomy-jejunal tube.The physician thinks he gets adequate decompression with this altered method.

• Brand Name: UNKNOWN JEJUNOSTOMY TUBE
• Type of Device: DH EF BALLOON TUBES 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: 9838964
• MDR Text Key: 199138315
• Report Number: 9611594-2020-00044
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2020
• 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