MAUDE Adverse Event Report: HALYARD HEALTH HALYARD CORFLO PEG REPLACEMENT FEEDING ADAPTER WITH ENFIT CONNECTOR; DH CPK PEG INITIAL PLACEMENT PRODUCTS

Model Number	50-6112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/16/2017
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 in-progress.All information reasonably known as of 22-aug-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 received.
Event or Problem Description
It was initially reported by the patient's father that a peg adapter snapped into two pieces.It was noted, that as a result, the tube stays open and exposed for contamination to enter in, or the stomach can empty itself until the issue is discovered.It was noted that reporter believes that bacteria went in and his son became ill.Extra caution was noted to be taken to prevent additional breaks.Additional information received on 25-jul-2017 from the patient's father stated that his son became sick 24 hours after a peg adapter break, which he believes caused his son's chest infection.A visit to the hospital was required in order to obtain and administer antibiotics.The father now uses sellotape as a preventative.No further information was received.
Additional Manufacturer Narrative
No sample was returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 10-oct-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).

• Brand Name: HALYARD CORFLO PEG REPLACEMENT FEEDING ADAPTER WITH ENFIT CONNECTOR
• Common Device Name: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6811513
• Report Number: 3009124963-2017-00044
• Device Sequence Number: 1735713
• Product Code: KNT
• UDI-Device Identifier: 20815149021588
• UDI-Public: 20815149021588
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: Patient Family Member or Friend
• Device Expiration Date: 03/31/2020
• Device Model Number: 50-6112
• Device Catalogue Number: 104621200
• Device Lot Number: 77611
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention