MAUDE Adverse Event Report: HALYARD HEALTH MIC* GASTRIC-JEJUNAL FEEDING TUBE KIT, GJ-TUBE 18 F; DH EF BALLOON TUBES PRODUCTS

Model Number	0650-18
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Peritonitis (2252); No Code Available (3191)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Admittance to icu.The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for (b)(4) was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 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).Device discarded by hospital.
Event or Problem Description
It was reported that following a whipples procedure on (b)(6) 2017, a mic* gj tube was placed in the patient.Following the surgery, after seven days of use, the tube fractured just below the triple port, affecting the balloon channel and causing the water to leak out and the balloon to fail.The tube had shifted from its original position, requiring a follow up surgical procedure to repair the stomach on (b)(6) 2017.The patient was admitted to the intensive care unit and was kept on total parenteral nutrition.Per additional information received from the hospital dietitian, the hospital has alleged that the patient developed peritonitis as a result of the tube failing and shifting from its original position.The surgery that was performed to repair the stomach was an omental patch.At the time of this call, the patient was still in the intensive care unit but was recovering well.No further information has been provided at this time.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6515988
• Report Number: 9611594-2017-00069
• Device Sequence Number: 13859892
• Product Code: KNT
• UDI-Device Identifier: 10680651958423
• UDI-Public: 10680651958423
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Dietician
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: 0650-18
• Device Catalogue Number: 109584201
• Device Lot Number: AA6193N39
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention