MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEONATE DUAL HEATED DUAL DRAIN; HUMIDIFIER NEBULIZER KIT

Model Number	IPN913843
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "heated expiratory wire circuit had a pinhole.Circuit was replaced and no issues".No patien injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).One unit of catalog number 880-15kit (neonate dual heated dual drain) and an additional expiratory side with the valve cap of neonate iso-gard were received for analysis.After functional testing, the valve cap of the additional expiratory side was inspected, and damage was observed in the valve.No pinholes were observed on the samples during the visual inspection.The full sample of 880-15kit was tested per leak test for neonatal circuits.No issues were found, the sample passed the test.The additional expiratory side was connected to full sample and cap valve was put on neonate iso-gard drain on expiratory side.Sample was tested per leak test for neonatal circuits.The sample failed the test.The additional expiratory side was connected to an air source and immersed into the water and bubbles were observed on the valve cap.This confirm that the leak is in valve cap of neonate iso-gard drain.The neonate iso-gard drain is supplied by an external vendor, therefore a notification will be sent to the vendor for further evaluation.
Event or Problem Description
It was reported "heated expiratory wire circuit had a pinhole.Circuit was replaced and no issues".No patien injury or harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "heated expiratory wire circuit had a pinhole.Circuit was replaced and no issues".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).Additional investigation information received indicates: the complaint is confirmed as the valve cap was found to be defective and leaking during functional testing.The sample was sent to the manufacturing site for further investigation.Upon further analysis, it was confirmed that the valve cap of the iso-gard drain was defective.The root cause of this issue has been determined to be manufacturing related.A non-conformance has been initiated by the manufacturing site to further investigate this issue.*the investigation findings and conclusion codes have been updated.

• Brand Name: HUDSON NEONATE DUAL HEATED DUAL DRAIN
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12597962
• Report Number: 3004365956-2021-00276
• Device Sequence Number: 4023603
• Product Code: OGG
• UDI-Device Identifier: 14026704660510
• UDI-Public: 14026704660510
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2021

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
• Device Model Number: IPN913843
• Device Catalogue Number: 880-15KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 11/26/2021; 02/22/2022
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/29/2021; 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown