MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 1.2 CM, 15 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-16-1.2-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Feeding Problem (1850); Pain (1994); Distress (2329); Caustic/Chemical Burns (2549); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for aa5341n32 was reviewed and the product was produced according to product specifications.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 by the patient's mother that her son, who has a chronic kidney disease, had a gastrojejunostomy (gj) tube placed and then afterward experienced retching, bleeding into the drain bag, groaning, gagging up clots, and burning skin on the neck from the acid.The hospital performed an xray and confirmed that the feeding tube was placed properly and told the mother the symptoms were due to the patient's severe reflux.Because of the child's reaction, however, the tube was removed and replaced with a mic key button and all symptoms have resolved.No further information has been provided at this time.
Additional Manufacturer Narrative
Visual examination of the sample revealed it to be in good condition.The molded head did not exhibit any flash, rough edges, or other visible defect.The gastric skives and jejunal skives were intact, with no tears.The internal septum was intact, without crossed lumen communication.The balloon was filled with 5cc of water, and was asymmetric in appearance.No failure was detected.The reported event could not be confirmed.Therefore, no root cause could be determined.All information reasonably known as of 19 apr 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 complaint (b)(4).

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6315892
• Report Number: 9611594-2017-00020
• Device Sequence Number: 406205
• Product Code: KNT
• UDI-Device Identifier: 10680651954937
• UDI-Public: 10680651954937
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Patient Family Member or Friend
• Device Expiration Date: 12/01/2017
• Device Model Number: 0270-16-1.2-15
• Device Catalogue Number: 991095493
• Device Lot Number: AA5341N32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 04/25/2017
• Patient Sequence Number: 1
• Patient Age: 13 MO