MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; KIT,HUMID,AQUAPAK,340ML,H2O,W/ADPT

Catalog Number	HUDRHP340U
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer was unpacking a case of this item and noticed that 9 were sent without adaptor.The bag that the item was wrapped in was sealed and intact.
Additional Manufacturer Narrative
The account reported that the customer was unpacking a case of this item and noticed that 9 were sent without adaptor and the bag that the item was wrapped in was sealed and intact.A photo was received for the investigation; the sample consists of one photograph, and the photo shows a side-by-side comparison of one aquapak with an adapter and one without the adapter; both aquapaks appear to be sealed.The reported problem was confirmed based on the photograph showing one aquapak with an adapter and one without the adapter.Based on the complaint details, it is likely the omission of the adapter was a manual error during product assembly; this complaint has been provided to the component manufacturing facility for further evaluation, and the quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: KIT,HUMID,AQUAPAK,340ML,H2O,W/ADPT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945991
• Report Number: 1417592-2026-54165
• Device Sequence Number: 13349271
• Product Code: BTT
• UDI-Device Identifier: 20193489139683
• UDI-Public: 20193489139683
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Device Catalogue Number: HUDRHP340U
• Device Lot Number: 23B633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown