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

Model Number	IPN913843
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
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 melting in a 1-2 inch portion during vent use".No patient harm or injury reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "heated expiratory wire circuit melting in a 1-2 inch portion during vent use".No patient harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one full 880-15kit neonate dual heated dual drain for investigation.During visual inspection, a large melted section of tubing was observed.It was observed that there were no breaks or bunches of wires in the tubing.The heated wires used in this circuit were insulated with a clear plastic flexible insulator coating with green stripes.The complaint has been confirmed, the tubing was melted.The melted section of the tubing was located at 10.5 inches from the grommet with the yellow connector.The melted portions of tubing measured approximately 1.25" in length.Melting can occur if the tubing is covered with sheets, blankets, towels, clothing or other materials.The ifu provided with this product includes warnings for the user against covering the tubing.The resistance of the circuit was measured to be 29.1 ohms which is within specification of 27.55-31.44 ohms.The ifu states, "do not place tubing on patient's skin.Do not cover tubing with sheets, blankets, towels, clothing, or other materials." the complaint of a breathing circuit melting has been confirmed.Since all heated wire circuit product codes are inspected 100% before leaving the manufacturing facility, it is unlikely that the failure was present at the time of release.The root cause for the failure is unintentional user error.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HUDSON NEONATE DUAL HEATED DUAL DRAIN
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 12287637
• Report Number: 3004365956-2021-00246
• Device Sequence Number: 20001731
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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
• Operator of Device: No Information
• Device Model Number: IPN913843
• Device Catalogue Number: 880-15KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 08/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VENT; VENT; VENT