MAUDE Adverse Event Report: MEDLINE-NAMIC MEDLINE; LHK CLEVELAND CLINIC HOSPITAL

Catalog Number	6012498502
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
"the customer reported that "blue 20ml syringes are not threading properly and air is entering into the manifold." no additional details are available related to the customer reported issue.
Additional Manufacturer Narrative
"the customer reported that "blue 20ml syringes are not threading properly and air is entering into the manifold." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.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.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.".

• Brand Name: MEDLINE
• Common Device Name: LHK CLEVELAND CLINIC HOSPITAL
• Manufacturer (Section D): MEDLINE-NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24584458
• Report Number: 3015910259-2026-00085
• Device Sequence Number: 9233893
• Product Code: OEZ
• UDI-Device Identifier: 10197344014231
• UDI-Public: 10197344014231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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: 6012498502
• Device Lot Number: 0000151319
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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