MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY* GASTRIC-JEJUNAL FEEDING TUBE KIT - 16 FR, 2.0 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-16-2.0-30
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, aa7205n18, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 18-sep-2018 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 (b)(4).
Event or Problem Description
It was reported a cross-lumen breach occurred on the jejunal feeding tube.The internal septum was compromised, allowing jejunal feeding to exit the gastric skives.
Additional Manufacturer Narrative
Correction: one sample device was returned.No product packaging was received.The tubing exhibited a very dark discoloration on the interior.The sample emitted a strong odor.The sample was examined under ambient light conditions.Slight tearing was observed at the second gastric skive.Feeding was simulated, using water, through the jejunal feed port.The water infused into the jejunal port exited the gastric skives.The area was examined under magnification.The internal septum which separates the two feed lumens exhibited a breach.The septum appeared somewhat lumpy.The complaint was confirmed.No root cause was identified.The cause for this incident could not be conclusively determined.All information reasonably known as of 16-nov-2018 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).

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7893951
• Report Number: 9611594-2018-00146
• Device Sequence Number: 19287438
• Product Code: KNT
• UDI-Device Identifier: 10680651956405
• UDI-Public: 10680651956405
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/01/2019
• Device Model Number: 0270-16-2.0-30
• Device Catalogue Number: 991095640
• Device Lot Number: AA7205N18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/21/2018
• Patient Sequence Number: 1