MAUDE Adverse Event Report: HUDSON 10MM DUAL LIMB ISO-GARD CIRCUIT, 5FT HT; HUMIDIFIER NEBULIZER KIT

Catalog Number	880-09KIT
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
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 "the circuit appeared to start to melt, there is no reported leak in the circuit.But the expiratory limb is discolored.The patient is prone 18 hours a day with mediation going through the circuit.Mucomyst and pulmozyme via aerogen and on nitric".No patient injury or consequence reported.Patient condition unknown at time of report.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 880-09kit 10mm dual limb iso-gard circuit, 5ft htd for investigation.During the visual inspection, no discoloration, defects, damages or melted portions were 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 yellow stripes.The resistance of the circuit at the yellow connector was measured to be 23.1 ohms which is within specification of 21.05-23.55 ohms.The resistance of the circuit at the blue connector was measured to be 22.3 ohms, which is within specification of 21.05-23.55 ohms.The ifu for this product states, "do not place tubing on patient's skin.Do not cover tubing with sheets, blankets, towels, clothing, or other materials." the complaint is not confirmed.Upon visual inspection, no discoloration, defects, damages or melted portions were observed.The resistance of the heated wire cables in the circuit measured within specification.A device history record review was performed with no evidence to suggest a manufacturing related cause.It is possible that the reported melted part was actually discoloration which could have been caused by spillage of medication on tubing.However, this discoloration could have been removed as part of the decontamination process.Since no discoloration was observed on the returned sample at the time of investigation, the complaint is unconfirmed.There was no problem found with the returned sample.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "the circuit appeared to start to melt, there is no reported leak in the circuit.But the expiratory limb is discolored.The patient is prone 18 hours a day with mediation going through the circuit.Mucomyst and pulmozyme via aerogen and on nitric".No patient injury or consequence reported.Patient condition unknown at time of report.

• Brand Name: HUDSON 10MM DUAL LIMB ISO-GARD CIRCUIT, 5FT HT
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 11740868
• Report Number: 3004365956-2021-00161
• Device Sequence Number: 4167585
• Product Code: OGG
• UDI-Device Identifier: 14026704658852
• UDI-Public: 14026704658852
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/09/2021

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 Catalogue Number: 880-09KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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