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	0270-16-2.0-22
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible, as no valid lot number has been provided.All information reasonably known as of 22 jun 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 (b)(4).Device not returned.
Event or Problem Description
It was reported that the feeding tube split inside the patient, and the jejunal feed is now getting into the patient's stomach.No further information has been provided at this time.
Additional Manufacturer Narrative
Correction: based on information received from the reporter, the product info has been updated.The device history record for lot aa7038n21 was reviewed and the product was produced according to product specifications.All information reasonably known as of 16 aug 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 - 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: 7632306
• Report Number: 9611594-2018-00072
• Device Sequence Number: 2412871
• Product Code: KNT
• UDI-Device Identifier: 10680651440911
• UDI-Public: 10680651440911
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: 0270-16-2.0-22
• Device Catalogue Number: 991095639
• Device Lot Number: AA7038N21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 08/20/2018
• Patient Sequence Number: 1