MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK* (CE); DH EF BALLOON TUBES PRODUCTS

Model Number	0120-16-3.5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 14apr2018 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 customer that the feeding tube broke under the external bolster where the stem of the tube meets the external bolster.The feeding tube was a week old.The home health nurse removed the remaining portion of the external bolster with a hemostat.There was no injury to the patient and the feeding tube was placed without any issues.The device was in use for one week prior to the break.No additional information was provided.
Additional Manufacturer Narrative
The device history record for the reported lot number, aa7317f55, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.One sample device returned.The molded head, tube and balloon appeared to be clean without any foreign substance on the exterior of the device.The original packaging was not returned with the device.The device could not be filled with the suggested amount of water due to an apparent breaking/separation of the silicone molded head portion of the mic-key from the bi-lumen tube.The inner portion of the molded head was examined, there material inside blocking the balloon lumen.The tip of the tube (proximal end) was also examined and exhibited a jagged appearance.The tip portion of the silicone molded head did not exhibit split or tearing.No root cause was identified.All information reasonably known as of 24-may-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).
Event or Problem Description
Per additional information the user stated, that the "patient has the tendancy to take a hold of the feeding tubes.".

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7439663
• Report Number: 9611594-2018-00047
• Device Sequence Number: 16417772
• Product Code: KNT
• UDI-Device Identifier: 10680651948738
• UDI-Public: 10680651948738
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: Nurse
• Device Expiration Date: 11/01/2019
• Device Model Number: 0120-16-3.5
• Device Catalogue Number: 991094873
• Device Lot Number: AA7317F55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/25/2018
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 48