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

Model Number	0120-14-2.3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The device history record for aa6061f08 was reviewed and the product was produced according to product specifications.All information reasonably known as of 13-sep-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.(b)(4).
Event or Problem Description
It was reported that the mic key split in half.The part remaining behind in the patient was passed rectally.Per additional information received 1 sep 2017, the event occurred after 21 days of use.No further information has been provided at this time.
Additional Manufacturer Narrative
One used device was returned for evaluation.Visual inspection revealed the device was slightly discolored with foreign substances on the exterior.The returned sample showed signs of damage at the molded head of the device.The device could not be filled with water due to the separation under the molded head.Upon examination, the molded head and feeding tube (not returned) were separated.There was tearing at the bonded location where the molded head an tube are joined.The tearing was viewed under 30x magnification and was found to be jagged in appearance.The manufacturing process was reviewed and it was determined that there were no activities or tools that could have caused this type of flaw in the tube component.The root cause could not be conclusively determined.All information reasonably known as of 27-sep-17 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

• Brand Name: MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK (CE)
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6870164
• Report Number: 9611594-2017-00128
• Device Sequence Number: 873544
• Product Code: KNT
• UDI-Device Identifier: 10680651948462
• UDI-Public: 10680651948462
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K993138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: Lay User/Patient
• Device Expiration Date: 03/01/2018
• Device Model Number: 0120-14-2.3
• Device Catalogue Number: 104273200
• Device Lot Number: AA6061F08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 09/29/2017
• Patient Sequence Number: 1
• Patient Age: 17 YR