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	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A visual inspection of the product involved was performed on three pictures provided by the customer.Customer photos show a 340 ml water reservoir still in the plastic dustcover bag which is partially torn, what appears to be an 040 humidifier adaptor with a white adaptor body inside of a plastic bag, and a close up of the label on the water reservoir indicating product code (b)(4) and lot number 20b211.Based on the photos provided, it cannot be determined that the aquapak humidifier adaptor would not screw on to the oxygen point.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.
Event or Problem Description
It was reported that "nicu had a new admission that required humidification.Aquapak humidifier adaptor did not screw onto the oxygen point.Adaptor does not thread.Clinical consequences: a new pack was opened and used successfully.No patient involvement".

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 11615857
• Report Number: 1417411-2021-00005
• Device Sequence Number: 3071423
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 05/28/2024
• Device Model Number: IPN049113
• Device Catalogue Number: 003-40
• Device Lot Number: 20B211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2020
• 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