MAUDE Adverse Event Report: NAMIC - MEDLINE INDUSTRIES; DBD-LHK, US, BEN TAUB GENERAL HOSP

Catalog Number	NAM0024
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "manifold setting including with the syringe are constantly coming loose".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 (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.
Event or Problem Description
Manifold and syringe connection issue.
Additional Manufacturer Narrative
It was originally reported that there was physician concern about the syringe-manifold connection issue "becoming unsafe for the patient due to introducing air." to date, no report of death, serious injury, medical intervention, follow-up care, or other adverse health impact has been received in relation to this reportable event.Additional updates made to: e1, h6.

• Common Device Name: DBD-LHK, US, BEN TAUB GENERAL HOSP
• Manufacturer (Section D): NAMIC - MEDLINE INDUSTRIES; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield; northfield, IL 60093-2753
• MDR Report Key: 22126480
• Report Number: 3015910259-2025-00044
• Device Sequence Number: 20656073
• Product Code: OES
• UDI-Device Identifier: 10195327536886
• UDI-Public: 10195327536886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2026

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?: No
• Device Catalogue Number: NAM0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 03/18/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown