MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY* LOW PROFILE GASTROSTOMY FEEDING TUBE, 14 FR, 3.5 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-14-3.5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The device history record for the reported lot number, aa8071f32, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 22-feb-2019 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).
Event or Problem Description
It was reported the parent stated the mic-key tube came out, but just the top piece of the device.The bottom piece remained in the gastrointestinal tract, but parents "managed to pull it out." no additional information was provided.
Event or Problem Description
Additional information received 22-feb-2019 stated.The patient moved her arm across and the top pulled off, the parents were there at the time and saw it happen.The dad was quick and saw the remainder of the tube and pressed gently on the patient's "tummy" and was able to catch the tip of the tube and pulled it out.There was no patient injury.No additional information was provided.
Additional Manufacturer Narrative
All information reasonably known as of 08-mar-2019 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
One used sample was received.The device was evaluated.The edges were relatively smooth and even, with no jagged tearing.The failure was confirmed.No root cause was identified.All information reasonably known as of 29-may-2019 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.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8363774
• Report Number: 9611594-2019-00032
• Device Sequence Number: 1915411
• Product Code: KNT
• UDI-Device Identifier: 10680651948509
• UDI-Public: 10680651948509
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2019

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: 03/01/2020
• Device Model Number: 0120-14-3.5
• Device Catalogue Number: 991094850
• Device Lot Number: AA8071F32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/22/2019; 05/07/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/13/2019; 05/30/2019
• Patient Sequence Number: 1