MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CMS,SQUEEZE,72,W/BALL,PG

Catalog Number	90400435
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the team went through almost all of them in one day due to it leaking air out of the top of them.Difficult time filling the buritrol.It was making a hissing sound.".
Additional Manufacturer Narrative
The account reported contrast controller leak, and the complaint described leaking air out of the top of them, difficult time filling the buritrol, and a hissing sound.Eight new, unused samples were returned for evaluation; visual evaluation did not reveal any defects, and functional evaluation was performed by connecting the spike to a saline bag and squeezing, with results found the samples to function as intended.Based on the investigation results, the reported event was not able to be confirmed at this time.Root cause remains inconclusive at this time as the reported defect was not able to be confirmed, and no action is required at this time as the reported event was not able to be confirmed.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: CMS,SQUEEZE,72,W/BALL,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50950419
• Report Number: 1417592-2026-54806
• Device Sequence Number: 21419646
• Product Code: IZI
• UDI-Device Identifier: 10193489068191
• UDI-Public: 10193489068191
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K903493
• 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): 09/29/2026

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: 90400435
• Device Lot Number: 0000139374
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2025
• 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: 01/29/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown