MAUDE Adverse Event Report: HALYARD HEALTH MIC* BOLUS GASTROSTOMY FEEDING TUBE, 16 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	0110-16LV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	10/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The device history record for aa7072d08 was reviewed and the product was produced according to product specifications.All information reasonably known as of 28-nov-17 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 when the patient came in to have the feeding tube replaced and was diagnosed with peritonitis.A ct scan was performed.Per additional information received on 10 nov 2017, the initial feeding tube was placed on (b)(6) 2017.Per additional information received on 14 nov 2017, the placement of the device was an initial placement.A halyard kit was used to place the device.The peritonitis was diagnosed on (b)(6) 2017.There were no issues with the stoma or the sutures that were placed.The patient was discharged after insertion of a new tube.Per additional information received 21 nov 2017, the feeding tube had been used for nutrison feed and oral medications.Additional information received on 22 nov 2017 stated that the feeding tube was replaced, and then the patient was diagnosed with peritonitis, which was confirmed via ct scan.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
Correction: the sample receipt date and usage of device selection were left off the initial report in error.One sample was received for evaluation.The balloon was filled with 5cc water and was observed for leaks.No leakage was detected from the balloon or balloon inflation port.The balloon was squeezed and manipulated, and still no leakage was observed.The water was extracted and the balloon was filled with methylene blue.The sample was placed on a blotter and left for a period of 30 minutes.There was no visible leakage.The reported failure could not be reproduced in the lab.The sample was examined for visible defects.No damage or defects were observed.No rough edges, excess adhesive, or foreign materials were present on the returned sample.No root cause for the reported issue could be determined.All information reasonably known as of 09 jan 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).

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7069726
• Report Number: 9611594-2017-00155
• Device Sequence Number: 102500
• Product Code: KNT
• UDI-Device Identifier: 10680651948042
• UDI-Public: 10680651948042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K842076
• 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): 12/25/2017

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: Other
• Device Expiration Date: 03/01/2020
• Device Model Number: 0110-16LV
• Device Catalogue Number: 991094804
• Device Lot Number: AA7072D08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 12/25/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other