MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-18-1.5-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 30 jul 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
It was reported that there was a hole in the jejunal lumen behind the balloon.No further information has been provided.
Additional Manufacturer Narrative
The sample evaluation confirmed the jejunal and gastric lumens had torn which allowed for an inner lumen crossover; however, there were no activities or tools that could cause this type of flaw in the tube component; the cause for this incident could not be conclusively determined.All information reasonably known as of 10-sep-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).

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7744644
• Report Number: 9611594-2018-00109
• Device Sequence Number: 1618390
• Product Code: KNT
• UDI-Device Identifier: 10680651441062
• UDI-Public: 10680651441062
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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: Other
• Device Expiration Date: 02/01/2019
• Device Model Number: 8270-18-1.5-30
• Device Catalogue Number: 104410600
• Device Lot Number: AA7051N27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1