MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; LHK - MCLAREN BAY REGION

Catalog Number	60022681B
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Syringe connection issue.
Additional Manufacturer Narrative
It was reported, "syringe within the kit would not connect to the manifold".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.
Additional Manufacturer Narrative
Update to d9: device available, not returned, update to e1: customer telephone and zip code, update to h3: device not evaluated, update to h6: type of investigation.

• Common Device Name: LHK - MCLAREN BAY REGION
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24607276
• Report Number: 3015910259-2024-00018
• Device Sequence Number: 21056502
• Product Code: OEZ
• UDI-Device Identifier: 20197344009296
• UDI-Public: 20197344009296
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/12/2026

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: 60022681B
• Device Lot Number: 24BBG031
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2023
• Supplement Date Received by Manufacturer: 05/21/2023
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 03/16/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic