MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK (CE); DH EF BALLOON TUBES PRODUCTS

Model Number	0120-12-1.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 26 jun 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the patient "ended up getting an infection in his gtube [gastrostomy tube] site after placing the new tube.It was a very rough 5 days with very high fevers but he had turned a corner and is finally doing much better.I don't believe that [the patient] was injured from the tube but i do think that his site was irritated from the off length of the tube and the insertion of the new tube caused much trauma to his site which led to the infection.He is still on oral and topical antibiotics but doing well now".
Additional Manufacturer Narrative
The device history record for the reported lot number, aa8316f44, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The device was evaluated and the failure was confirmed.A root cause could not be established.All information reasonably known as of 30-oct-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 halyard health 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
The product involved in the report has been returned and is being processed for evaluation.The investigation is in progress.All information reasonably known as of 24 jul 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 halyard health 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.

• Brand Name: MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK (CE)
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8736992
• Report Number: 9611594-2019-00120
• Device Sequence Number: 1904965
• Product Code: KNT
• UDI-Device Identifier: 10680651948318
• UDI-Public: 10680651948318
• 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: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/01/2020
• Device Model Number: 0120-12-1.7
• Device Catalogue Number: 991094831
• Device Lot Number: AA8316F44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 07/01/2019; 10/08/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/24/2019; 10/31/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEOCATE JR.; PREVACID; NEOCATE JR.; PREVACID
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 MO