MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CIRCUIT, 90"EXP,1BV,3L

Catalog Number	DYNJAA9120
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on 2/3/2026, "the circuit was not holding pressure" during the case.The facility noted that there was a "seam found along circuit that was not sealed properly" leading to leaking.Once the issue was identified, the circuit was replaced.Per the facility, the patient was "unaffected." to date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on 2/3/2026, "the circuit was not holding pressure" during the case.The facility noted that there was a "seam found along circuit that was not sealed properly" leading to leaking.
Additional Manufacturer Narrative
Update to h6.After further investigation and based on nature of defect, the root cause was determined to be manufacturing related; however a more specific cause cannot be determined based on information and photo provided.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: CIRCUIT, 90"EXP,1BV,3L
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24497717
• Report Number: 1417592-2026-00173
• Device Sequence Number: 10533592
• Product Code: CAH
• UDI-Device Identifier: 10080196827367
• UDI-Public: 10080196827367
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAA9120
• Device Lot Number: 25GBV209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 YR
• Patient Sex: Female