MAUDE Adverse Event Report: HALYARD HEALTH CORFLO PEG KIT WITH ENFIT CONNECTOR; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	50-6012E1
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Human Factors Issue (2948)
Health Effect - Clinical Codes	Vomiting (2144); Choking (2464)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 28 jun 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).
Event or Problem Description
It was reported that a doctor cut and pushed the patient's peg tube inside the stomach, in order to place a mic key device.A week later, the patient became unwell and was apparently choking.When the parent intervened, the patient vomited up the cut peg.No further information provided.

• Brand Name: CORFLO PEG KIT WITH ENFIT CONNECTOR
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7656980
• Report Number: 3006646024-2018-00027
• Device Sequence Number: 163513
• Product Code: KNT
• UDI-Device Identifier: 20815149021748
• UDI-Public: 20815149021748
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: Physician
• Device Model Number: 50-6012E1
• Device Catalogue Number: 104620401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/02/2018
• Patient Sequence Number: 1
• Patient Age: 6 YR