MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE GASTROSTOMY FEEDING TUBE - 14 FR, 2.0 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-14-2.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Hypersensitivity/Allergic reaction (1907); Pain (1994); Vomiting (2144)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of (b)(6) 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 halyard health 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 halyard health.Halyard health 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).Device not returned.
Event or Problem Description
It was reported the patient had a suspected allergy to silicone.The gastrostomy tube was changed for another size device.The protective dressing was kept dry in an effort to prevent granulation tissue growth.In (b)(6) 2018, the patient had the biggest granulation growth over the entire stoma site.The patient was hospitalized for 22-days and received a series of antibiotics.The patient had been vomiting.The family member is now using silver dressing to stop the granulation but the patient remains in pain.A debridement surgical procedure was performed and the device was changed.No additional information was provided.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7470115
• Report Number: 9611594-2018-00061
• Device Sequence Number: 1051403
• Product Code: KNT
• UDI-Device Identifier: 10680651948455
• UDI-Public: 10680651948455
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K993138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: Patient Family Member or Friend
• Device Model Number: 0120-14-2.0
• Device Catalogue Number: 991094845
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/27/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Weight: 12