MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; CIRCUIT, 90"EXP,1BV,3L,GSL,MASK45

Catalog Number	DYNJAA0111
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the "tape" to attach the balloon is missing, so the bag is falling off.The crna had a circuit attached to the patient.When air was pushed through to breathe for the patient, the bag fell off the circuit due to not having the tape attached when it was taken out of the bag to use.The crna was able to switch out circuit in enough time for the patient.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.
Event or Problem Description
The "tape" to attach the balloon is missing, so the bag is falling off.

• Brand Name: MEDLINE
• Common Device Name: CIRCUIT, 90"EXP,1BV,3L,GSL,MASK45
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center 106; nuevo laredo, 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25262285
• Report Number: 3004122598-2026-00011
• Device Sequence Number: 10511706
• Product Code: CAH
• UDI-Device Identifier: 10080196969296
• UDI-Public: 10080196969296
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K925217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAA0111
• Device Lot Number: 25JBA843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown