MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEED TUBE KIT EXTEN-SET,14 FR,1.7 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-14-1.7-30
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "when injecting contrast agent into jejunal feeding port, it came out in stomach not in jejunam.The patient is an infant and it was found when administering contrast agent." there was no reported injury.
Additional Manufacturer Narrative
The sample is reportedly available for this complaint but was not returned.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 23-mar-2023 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).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.Device not returned.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 19-apr-2023 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).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.
Additional Manufacturer Narrative
H6 investigation findings: inappropriate use additional information: b5.The device history record for the reported lot number, 30195885, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The device was evaluated.The molded head, tube and balloon appeared to have slight discoloration on the exterior and interior of the device.The original packaging was not returned with the device.There was slight whitish residue on the exterior of the tubing.The tubing was decontaminated to prepare for evaluation and examination.The balloon was unable to be filled with water due to the damage (burst) appearance.It was also noticed that the portion of jejunal tubing by the balloon area appeared to have some tearing effect.Under magnification, the tearing effect appeared to be jagged.Flushing was simulated using water mixed blue dye through the jejunal feed port.There was an observance of colored liquid droplets leaking out of the same opening in the jejunal tubing that was observed earlier.Flushing was simulated using water mixed blue dye also through the gastric feed port and there was an observance of colored liquid exiting out of gastric skives.The tearing effect opening at the jejunal tubing was the area where the colored liquid leaks out during flushing of the jejunal port.Based on the customer comments and details added in product information section related to "it was also reported that an inexperienced doctor might have injected nutrition into inflation port by mistake and balloon broke."; it was determined that, the balloon was already filled with water and the doctor injected nutrition through the inflation port by mistake, this caused the balloon to burst and damage the gastric and jejunal lumens, this event seems to be a user related incident.Ther root cause was inappropriate use.All information reasonably known as of 10-may-2023 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).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 or Problem Description
Additional information received 28-apr-2023 stated "it was also reported that an inexperienced doctor might have injected nutrition into inflation port by mistake and balloon broke.".

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEED TUBE KIT EXTEN-SET,14 FR,1.7 CM
• Common Device Name: 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: 16600114
• Report Number: 9611594-2023-00042
• Device Sequence Number: 14933495
• Product Code: KNT
• UDI-Device Identifier: 00350770470429
• UDI-Public: 00350770470429
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2023

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: Health Professional
• Device Expiration Date: 05/10/2024
• Device Model Number: 8270-14-1.7-30
• Device Catalogue Number: 8270-14-1.7-30
• Device Lot Number: 30195885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 04/28/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/20/2023; 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown