MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW PROFILE GASTROSTOMY FEEDING TUBE, 14 FR, 2.3 CM; DIGESTHEALTH ENTERAL FEED TUBE KITS

Model Number	0120-14-2.3
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2017
Type of Reportable Event	Malfunction
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 or sample was provided.Root cause could not be determined.All information reasonably known as of 20jul2017 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.(b)(4).
Event or Problem Description
It was reported by the caregiver that the patient pulled the device out of the stomach on (b)(6)2017.A portion of the stem remained in the patient's intestines.The patient was taken to the doctor who advised the caregiver to allow the patient to pass the broken portion.An x-ray was taken by a gi specialist who confirmed about an inch long stem of the device was in patient's intestine.The caregiver stated, the broken portion of the tube was passed by the patient in the stool three weeks later.The caregiver stated that the patient was sized 1-2 years ago, weight stable, and no growth.There were no changes in formula.Anti-inflammatory and anti seizure medications added.There were 6 cc of sterile water placed in the balloon.The caregiver stated that the patient is currently doing well.No additional information was provided at this time.
Additional Manufacturer Narrative
Correction: it was previously reported in error that the sample was returned.All information reasonably known as of 09aug2017 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).

• Common Device Name: DIGESTHEALTH ENTERAL FEED TUBE KITS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6730759
• Report Number: 9611594-2017-00099
• Device Sequence Number: 16357663
• Product Code: KNT
• UDI-Device Identifier: 10680651948462
• UDI-Public: 10680651948462
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Patient Family Member or Friend
• Device Model Number: 0120-14-2.3
• Device Catalogue Number: 991094846
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/09/2017
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 47