MAUDE Adverse Event Report: HALYARD HEALTH CORFLO® PEG KIT; DH CPK PEG INITIAL PLACEMENT PRODUCTS

Model Number	30-5020
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 3 april 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 not returned.
Event or Problem Description
A report was received stating the patient had the tube placed on (b)(6) 2017.The patient had an abdominal x-ray on (b)(6) 2017 (5 days later).The x-ray revealed fluid in the patient's abdomen and the patient was then taken back to the operating room (or).The bumper of the tube was completely was no longer positioned in the stomach.The surgeon repaired the stomach.When asked what procedure the surgeon performed it was noted to be a gastrostomy with placement of a gastrostomy tube.The surgeon "basically sutured the hole and placed another tube down lower to allow the stomach to heal." when asked the patient's current status it was noted, "the patient is very sick in icu." it could not be confirmed if the patient was in the icu before this procedure and clinician stated she believes so because the patient has been in and out of the icu lately had a lot of comorbidities.However, the clinician could not be certain.The patient also had a tracheostomy tube placed on the same day of the (b)(6) 2017 procedure.

• Brand Name: CORFLO® PEG KIT
• Common Device Name: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6454079
• Report Number: 3009124963-2017-00009
• Device Sequence Number: 588107
• Product Code: KNT
• UDI-Device Identifier: 20815149024084
• UDI-Public: 20815149024084
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2017

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: Other Health Care Professional
• Device Model Number: 30-5020
• Device Catalogue Number: 104587901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• Initial Report FDA Received Date: 04/03/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 109