MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 16 FR, 3.0 CM; DH EF BALLOON TUBES PRODUCTS

Model Number 8270-16-3.0-45

Device Problems Material Discolored (1170); Material Fragmentation (1261); Device Emits Odor (1425)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot aa8267n52 was reviewed and the product was produced according to product specifications.All information reasonably known as of 08 jun 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 complaint database and identified as complaint (b)(4).

Event Description

It was reported by the hospital via the distributor that the gastro-jujunal (gj) tube fractured whilst in situ.Approximately 44cm of the jujunal extension part was passed by the patient.There was no injury to the patient.A new tube was placed.No further information provided.

Manufacturer Narrative

Correction: per information provided by the distributor, the event date (b3) has been corrected from the previous report.No sample was returned for evaluation by avanos, however, photos of the device in question were provided.The sample photo provided showed a tear in the tube.The cause for the tear in the tube is indeterminate at this time and would require analysis of outside factors subsequent to the manufacture of the device.Per incident comments, the device was in use for an extended period of time (more than 90 days), which indicates that device did not show this defect at time of placement and the tube performed as intended.All information reasonably known as of 15 jul 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.

Event Description

Per additional information received 22 jun 2020, the tube had been in place for 239 days.The following medications were provided via the tube: atorusatatin, clopidogrel, alfacalcidol, paracetamol.The feed provided was 1000ml nutrison energy multifibre.The balloon had been inflated with 8ml of fluid.The new tube was placed 4 may 2020, the corrected day of event.Per a statement from the distributor, vygon, the tube was discolored with a strong odor.They believe this is due to fungus colonization of the tube.

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 16 FR, 3.0 CM
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10129142
• MDR Text Key: 199260155
• Report Number: 9611594-2020-00096
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770441009
• UDI-Public: 00350770441009
• Combination Product (y/n): N
• PMA/PMN Number: K922667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2020
• Device Model Number: 8270-16-3.0-45
• Device Catalogue Number: N/A
• Device Lot Number: AA8267N52
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2020
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 57