MAUDE Adverse Event Report: CONCHASMART 22MM SGL HTD LIMB CIRC KIT; HUMIDIFIER NEBULIZER KIT

Model Number	IPN913836
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
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 "circuit melted".No patient injury or harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "circuit melted".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one full 870-19kit circuit for investigation.During visual inspection four large melted sections were observed.Two of the melted sections had melted all the way through the tubing.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 blue stripes.The melted sections of the tubing were located at 33.5", 36", 39", and 45" from the elbow connector end.The melted portions of tubing measured approximately 1.5", 1.75", 2", and 1.25" in length respectfully.The resistance of the circuit was measured to be 13.6 ohms, which is within specification of 12.8-14.3 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 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.A device history record review was performed with no evidence to suggest a manufacturing related issue.The root cause for the failure is unintentional user error.No further action required.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: CONCHASMART 22MM SGL HTD LIMB CIRC KIT
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 11696897
• Report Number: 3004365956-2021-00155
• Device Sequence Number: 19710830
• Product Code: OGG
• UDI-Device Identifier: 14026704660398
• UDI-Public: 14026704660398
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/31/2021

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: IPN913836
• Device Catalogue Number: 870-19KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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