MAUDE Adverse Event Report: HALYARD HEALTH MIC* GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT; DH EF BALLOON TUBES PRODUCTS

Model Number	0650-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 27-mar-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).Device not returned.
Event or Problem Description
It was reported the device was coiled/knotted in the patient's stomach and it was also suspected it may be partially buried in the gastrointestinal tract.This caused immediate cause for concern for the healthcare providers.Additional information received 14-mar-2018 stated all is well.The patient went for a procedure and the tube was knotted but no longer buried.The healthcare providers were able to cut externally and remove the device endoscopically with a snare.The device was replaced with another transgastric jejunal tube.No additional information was provided.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7383253
• Report Number: 9611594-2018-00043
• Device Sequence Number: 16406915
• Product Code: KNT
• UDI-Device Identifier: 10680651958423
• UDI-Public: 10680651958423
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K921370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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 Health Care Professional
• Device Model Number: 0650-18
• Device Catalogue Number: 109584201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/29/2018
• Patient Sequence Number: 1