MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTROSTOMY FEEDING TUBE, EXTENSION SETS WITH ENFIT CONNECTORS - 14 FR; DH EF BALLOON TUBES PRODUCTS

Model Number 8140-14-1.0

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Inflammation (1932); No Code Available (3191)

Event Date 07/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot aa9014f76] was reviewed and the product was produced according to product specifications.All information reasonably known as of 13 nov 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 complaint database and identified as complaint (b)(4).Device not returned.

Event Description

It was reported that the wrong size tube was in the packaging and it was alleged that as a result, the patient experienced inflammation and gastric leakage at the stoma site which required unspecified medical therapy.Additional information has been requested but not yet received.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 16 dec 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 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.

Manufacturer Narrative

All information reasonably known as of 26 nov 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 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 14 nov 2019, patient information provided.The tube that was alleged to be in the packaging was ch 14, 2.0cm, with lot aa2331f21.The mother of the patient treated the inflammation along with the home care team.

Manufacturer Narrative

H6 conclusion code: cause traced to distributor.One mic key sample with two extension sets were returned inside an opened mic key kit box.The lot number on the box was aa9014f76, as reported.The lot of the returned mic key device was aa2331f21.Device history records for both lots were reviewed.The lot of the returned device, aa2332f21,) was manufactured on 23 nov 2012 and the lot on the label of the returned packaging, aa9014f76, was manufactured on jan 15 of 2019.These lots were not held together in the manufacturing plant, nor in the distribution center at any point prior to sale.Both lots were shipped to the nutricia distribution center in 2012 and 2019 respectively.It is therefore likely that the mix up occurred at the customer distribution center.There is no root cause determined for the patient reaction reported.All information reasonably known as of 07 jan 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.

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE, EXTENSION SETS WITH ENFIT CONNECTORS - 14 FR
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9324390
• MDR Text Key: 166498268
• Report Number: 9611594-2019-00214
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651427257
• UDI-Public: 10680651427257
• Combination Product (y/n): N
• PMA/PMN Number: K043114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2020

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?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2021
• Device Model Number: 8140-14-1.0
• Device Catalogue Number: N/A
• Device Lot Number: AA9014F76
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 11/14/2019; 12/10/2019; 01/03/2020
• Supplement Dates FDA Received: 11/27/2019; 12/17/2019; 01/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR