MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW PROFILE GASTROSTOMY FEEDING TUBE, 16 FR, 3.0 CM; DIGESTHEALTH ENTERAL FEED TUBE KITS

Model Number	0120-16-3.0
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Pneumonia (2011)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 02may2017 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 (b)(4) 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 (b)(4).(b)(4) 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 (b)(4) 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 a (b)(4) product is defective or caused serious injury.
Event or Problem Description
It was reported by the caregiver that the mic-key feeding tube placed on (b)(6) 2017 collapsed internally.The balloon was intact; however, feeding became slow after a week or two of placement.When trying to vent the patient¿s stomach the caregiver use a paper clip to try and unclog the feeding tube.This did not work and the patient began coughing and aspirated.The patient was hospitalized from (b)(6) 2017 for aspiration pneumonia.This patient was sent home from the hospital with antibiotics.The mic-key feeding device was replaced (b)(6) 2017.Currently the patient is in stable condition and well.No longer taking antibiotics.No additional information was provided.

• Common Device Name: DIGESTHEALTH ENTERAL FEED TUBE KITS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6546333
• Report Number: 9611594-2017-00075
• Device Sequence Number: 19090860
• Product Code: KNT
• UDI-Device Identifier: 10680651948721
• UDI-Public: 10680651948721
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K993138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

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?: Yes
• Operator of Device: Other Caregivers
• Device Expiration Date: 06/01/2018
• Device Model Number: 0120-16-3.0
• Device Catalogue Number: 991094872
• Device Lot Number: AA6181F03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/04/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 48