MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 16 FR, 2.0 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-16-2.0-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
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 in-progress.All information reasonably known as of 27-nov-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 (b)(4).Device not returned.
Event or Problem Description
It was reported that a patient had to have a replacement tube because the original broke in two pieces between the balloon and the external bolster of the gastric-jejunal tube.There was no injury to the patient, but the patient had to received general anesthesia and a scope to remove the broken tube.Additional information received on 13-nov-2017 stated that the tube was placed on (b)(6) 2017 and the incident occurred on (b)(6) 2017.The patient was discharged from the hospital.However, after the remained of the tube was removed by endoscope under general anesthesia, the patient had to stay one night in the pediatric intensive care unit under observation.
Additional Manufacturer Narrative
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 19-dec-2017 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 GASTRIC-JEJUNAL FEEDING TUBE KIT - 16 FR, 2.0 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7066973
• Report Number: 9611594-2017-00151
• Device Sequence Number: 19105306
• Product Code: KNT
• UDI-Device Identifier: 10680651956405
• UDI-Public: 10680651956405
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 0270-16-2.0-30
• Device Catalogue Number: 991095640
• Device Lot Number: AA7065N16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/22/2017
• Patient Sequence Number: 1
• Patient Age: 12 YR