MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* GASTROSTOMY FEEDING TUBE EXTENSION SETS WITH ENFIT® CONNECTOR; DH EF BALLOON TUBES PRODUCTS

Model Number	8140-16-2.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pneumonia (2011); Sepsis (2067); Skin Inflammation (2443)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.No root cause could be determined.The device history record for aa6060f08 was reviewed and the product was produced according to product specifications.All information reasonably known as of 2017-05-05 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 by the patient that they received a new peg tube in the beginning of 2017 that they had never used before.After the placement of this peg, the patient alleges that an allergic reaction began outside of the stomach, in the form of wounds, which the patient treated themselves.After that, the patient alleges stomach flu like symptoms and increasing weakness, with difficulty breathing, even on respirator.The patient went to the hospital where the patient alleges they were diagnosed with sepsis and pneumonia.On the advice of the hospital physician, the peg tube was switched out with a type that the patient had used before, upon which the patient alleges that all symptoms resolved.The patient reported that they have completely recuperated.No further information has been provided at this time.
Additional Manufacturer Narrative
All information reasonably known as of 11 may 2017 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).
Additional Manufacturer Narrative
All information reasonably known as of 25 may 2017 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 (b)(4).
Event or Problem Description
Per additional information received, the patient reported to the distributor that when the product was replaced, it was replaced with earlier received stock that she still had on hand.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6559514
• Report Number: 9611594-2017-00077
• Device Sequence Number: 13701813
• Product Code: KNT
• UDI-Device Identifier: 10680651427486
• UDI-Public: 10680651427486
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2017

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: 02/01/2018
• Device Model Number: 8140-16-2.5
• Device Catalogue Number: 104274800
• Device Lot Number: AA6060F08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 05/12/2017; 06/02/2017
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 26