MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; RESUS,ADLT,MASK,BAG RESERVOIR

Catalog Number	CPRM4416
Medical Device Problem Codes	Fitting Problem (2183); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "trying to attach the mask to the bag and could not because the connector was misshapen and would not fit.The connector is hard plastic and could not be manipulated".
Additional Manufacturer Narrative
The account reported finding the sample "mask cannot connect to bag," and the complaint noted the issue did not occur during use and no injury occurred.A sample was received for investigation; it was visually inspected and compared to a reference unit, and the mask connector was observed to be deformed and not circular in shape, preventing attachment to the resuscitation bag.Medline could confirm the product failed to meet specifications.Medline could not confirm the cause of the issue, and no trends were identified.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: RESUS,ADLT,MASK,BAG RESERVOIR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50818160
• Report Number: 1417592-2026-44591
• Device Sequence Number: 10210516
• Product Code: BTM
• UDI-Device Identifier: 10888277700482
• UDI-Public: 10888277700482
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K012842
• 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): 09/16/2026

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: CPRM4416
• Device Lot Number: 575675
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/23/2026
• 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: 01/20/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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