MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP-NAMIC MEDLINE; DBD-LHK, US, CLEVELAND CLINIC HOSP

Catalog Number	NAM0023B
Medical Device Problem Codes	Material Twisted/Bent (2981); Air/Gas in Device (4062)
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
According to the customer contact, "blue 20ml syringes are not threading properly and air is entering into the manifold" and "035 x 260 j wire kdl is flimsy, kinky.".
Additional Manufacturer Narrative
According to the customer contact, "blue 20ml syringes are not threading properly and air is entering into the manifold" and "035 x 260 j wire kdl is flimsey, kinky." 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 1417592 on (b)(6) 2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Additional Manufacturer Narrative
According to customer contact, "035 x 260 j wire kdl is flimsy, kinky." no additional details are available related to the customer reported 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.After further investigation, a supplemental mdr was submitted to correct the identified issue and component from syringe to guidewire.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.-update to b5: describe event or problem.-update to h6: medical device problem code (a) -update to h6: component code (g) -update to h11: additional manufacture narrative -correction to h7: there was no remedial action associated with the component -correction to h9: there is no recall number is associated with the component.
Event or Problem Description
According to customer contact, "035 x 260 j wire kdl is flimsy, kinky.".

• Brand Name: MEDLINE
• Common Device Name: DBD-LHK, US, CLEVELAND CLINIC HOSP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP-NAMIC; 10 glen falls technical park; technical park drive; glen falls NY 12801 3864
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24629855
• Report Number: 3015910259-2026-00090
• Device Sequence Number: 18315017
• Product Code: OEZ
• UDI-Device Identifier: 10198459148316
• UDI-Public: 10198459148316
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: NAM0023B
• Device Lot Number: 25ABV068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/05/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-26-025-FGX2
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown