MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC NAMIC; SQUEEZE,CMS,BNS-OEM

Catalog Number	88000435
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 air entered the pressure measurement system and subsequently air was administered into the patient.The customer reported there was an air leak detected on "the pressure measuring system" and noted that the "glued connection was crooked".The customer reported they are unable to identify the cause of air entering the system due to another leak identified between the "contrast tube and the connection to the contrast container".The customer reported "resuscitation was performed" as a result of the air leak, but the patient is "doing well".No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, therefore, 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 customer, on (b)(6) 2025 air entered the pressure measurement system and subsequently air was administered into the patient.
Additional Manufacturer Narrative
The originally reported air leak issue reportedly occured during a "procedure on the hck.".

• Brand Name: NAMIC
• Common Device Name: SQUEEZE,CMS,BNS-OEM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield; northfield, IL 60093-2753
• MDR Report Key: 23838982
• Report Number: 3015910259-2025-00112
• Device Sequence Number: 9571965
• Product Code: IZI
• UDI-Device Identifier: 10193489140170
• UDI-Public: 10193489140170
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K903493
• 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): 03/18/2026

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: 88000435
• Device Lot Number: 0000163510
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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 Sex: Unknown