MAUDE Adverse Event Report: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR; HUMIDIFIER NEBULIZER KIT

Model Number	IPN049113
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
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 visual inspection of the product involved was performed on two pictures provided by the customer.Customer photos show an 040 humidifier adaptor with a clear snap cap and white adaptor body.One image shows a 340 ml water reservoir in the customer photo along with the humidifier adaptor packaging indicating adaptor lot 09e20, product code 000-40, is involved in the complaint.The adaptor was pictured from above in both photos and not in profile or from below.Because of the angle of the photos provided, it cannot be determined that the adaptor is faulty or would not screw or fit on to the flow meter.Sample needed to confirm complaint issue.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 that "aquapak humidifier adaptor is faulty and would not screw or fit on to the flow meter.Clinical consequences: none - prior to use on patient during inspection/functional testing".

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 11613181
• Report Number: 1417411-2021-00004
• Device Sequence Number: 19600804
• Product Code: OGG
• UDI-Device Identifier: 14026704627568
• UDI-Public: 14026704627568
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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 Expiration Date: 06/01/2024
• Device Model Number: IPN049113
• Device Catalogue Number: 003-40
• Device Lot Number: 20B217
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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