MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTOR - ENDOSCOPIC/RAD,18FR; DH EF BALLOON TUBES PRODUCTS

Model Number 8250-18

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 18-may-2022 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).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.

Event Description

Avanos medical 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 9611594-2022-00066 for the first event.Refer to 9611594-2022-00067 for the second event.It was reported there was an issue where the label was rubbing off of the g-j tube (ie: gastric and jejunal labels rubbing off actual tubing).There was no reported injury.Additional information received 28-apr-2022 stating it was reported by nursing that the label rubbed off sooner than this and tape was put on to help identify the tubes, the date of exact rubbing off is unknown.No medical intervention was required.

Manufacturer Narrative

Correction:d1, d4 and g4.Additional information: b5.All information reasonably known as of 13-jun-2022 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)(6).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.

Event Description

Additional information received 24-may-2022 regarding stoma/tube care information as follows: 1) wound cleanser is used on the stoma site only ¿ 1x a day nursing is instructed to clean the stoma site and replace a dry dressing over.We do not routinely clean the feeding tube itself unless it is visibly soiled (ie with bodily fluids, etc ¿ in which case we would also use wound cleanser.This does not happen often.) 2) site care ¿ stoma care ¿ is performed every day and each time the stoma is 'soiled' or becomes wet from perspiration/sweat, showering, etc.3) per report from our nutritionist, the tube was in place less than '6-weeks before the labels wore off.'.

• Brand Name: MIC GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTOR - ENDOSCOPIC/RAD,18FR
• 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
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14453672
• MDR Text Key: 300324118
• Report Number: 9611594-2022-00068
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770445458
• UDI-Public: 00350770445458
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921370
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8250-18
• Device Catalogue Number: N/A
• 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: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Prefer Not To Disclose