MAUDE Adverse Event Report: Medline Industries, LP HUDSON RCI; DBD-AQUAKPAK BUBBLE HUM,540ML,W/ ADAPTER

Catalog Number	005-40
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "customer had received 1ea leaked bottle despite no damage to the carton box.".
Additional Manufacturer Narrative
The account reported finding one ea was received leaking.Multiple photographs were submitted for investigation; the pictures show that the water has leaked from the aquapak bottle into the packaging, and water droplets can be seen in the plastic bag that the aquapak is in.Trending was reviewed and there have been 0 additional reported complaint(s) for this issue for the account in the past 6 months; the cause was documented as cannot determine cause.This complaint has been provided to the vendor 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: HUDSON RCI
• Common Device Name: DBD-AQUAKPAK BUBBLE HUM,540ML,W/ ADAPTER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945729
• Report Number: 1417592-2026-54127
• Device Sequence Number: 10348673
• Product Code: BTT
• UDI-Device Identifier: 20197344007155
• UDI-Public: 20197344007155
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 09/24/2026

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: 005-40
• Device Lot Number: 22D003
• 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: 10/02/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown