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

Model Number	50-6016E1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/30/2018
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.All information reasonably known as of 02-mar-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.(b)(4).
Event or Problem Description
It was reported the peg end broke.It broke during the night following the previous feed, thus the previous feed and gastric contents leaked all over patient.The device broke at the joining point of the y-connector.The family member stated the clamp was on the clamped position but this also failed to stop back-flow of the gastric contents.The gastric contents caused gastric burns to the patient's skin.The burned skinned is being treated with dressings.A new clamp end was placed on the device.Additional information received 21-feb-2018 stated the patient had a 16 french corflo peg placed in (b)(6) 2017.The peg-y end snapped off overnight on (b)(6).Although the clamp was closed, it failed to stop the stomach contents from leaking onto the patients skin from the peg tube.The patient was unable to communicate and as the incident was overnight the skin exposure to stomach acid resulted in a 2nd degree burn to the skin.The patient was treated in the accident and emergency department (a&e).The burn was too serious to treat locally.Initially it was thought that the patient would need a skin graft, although this has not occurred.The patient is now being treated with dressings and ongoing additional care.No additional information was received.

• Common Device Name: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7313096
• Report Number: 3006646024-2018-00005
• Device Sequence Number: 1736583
• Product Code: KNT
• UDI-Device Identifier: 10815149021765
• UDI-Public: 10815149021765
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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: Nurse
• Device Model Number: 50-6016E1
• Device Catalogue Number: 104620700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 33 YR